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Research and Clinical Trials

Enrolling New Patients

The following studies are currently enrolling new patients.

DRCR Protocol W

Intravitreous Anti-VEGF Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk

A multi-center study being conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) sponsored by the National Institutes of Health, the U.S. Department of Health and Human Services.

General Information for a Patient Who May Want to Be a Participant in this Study

Your eye doctor is taking part in a study being conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net). This Network includes over 100 eye centers in the United States and Canada that specialize in the care of patients with diabetic retinopathy. The study is being funded by the National Eye Institute, which is a part of the National Institutes of Health, a branch of the U.S. Department of Health and Human Services that funds medical research, by the JDRF, and by Regeneron Pharmaceuticals, Inc., which is the company providing drug for this study.

If you have diabetic retinopathy and think you might be interested in taking part in the study, you will be given a document called an Informed Consent Form, which will provide a written explanation of the study in more detail. Your doctor and her/his staff will discuss the study with you and answer any questions you have. You will be given as much time as you may need to decide if you want to take part in the study. This manuscript will tell you about diabetic retinopathy and the treatments that are available as standard care. Eyes with diabetic retinopathy like yours are at a high risk of developing two complications that can affect vision: 1) proliferative diabetic retinopathy (PDR) or 2) diabetic macular edema (DME). Proliferative Diabetic Retinopathy (PDR) is a disease where new blood vessels and scar tissue form on the surface of the retina (the light sensitive tissue which lines the back of the eye), because of poor blood flow from diabetes. These new blood vessels can bleed into the middle of the eye or pull (detach) the retina off of the back wall of the eye. This can lead to loss of vision or even blindness that cannot always be fixed even with the best treatments available. Diabetic Macular Edema (DME) is the term used for swelling in the small central part of the retina used for sharp straight- ahead vision due to diabetes. The blood vessels are weakened by diabetes and may become leaky. This causes the retina to become thickened or swollen. Swelling of the central part of the retina could lead to decreased vision.

How are PDR and DME usually treated?

When vision is reduced from these complications, an injection into the eye may be given of a drug that blocks a substance called vascular endothelial growth factor (“anti-VEGF drug”).

Anti-VEGF drugs decrease the growth of new blood vessels and stop leakage of fluid. For eyes that are at high risk for developing these complications, the diabetic retinopathy is watched closely by an ophthalmologist but often not treated until it worsens to DME involving the center of the retina or advanced PDR, when these complications are likely to affect vision if left untreated.

Interested in this study and ready to enroll?

Click Here

What are the treatments being evaluated in this study?

We are doing a study to find out if periodic anti- VEGF injections into the eye can lower the chances of developing either PDR or DME. We [Protocol Version 1.0] Version 1.0 9/1/15 know that frequent injections can stabilize and sometimes improve vision in eyes that already have PDR or DME.

However, it is possible that the treatment will not bring all of the vision back that may have been lost from PDR or DME. Starting less frequent injections now may keep your eye from losing vision from PDR or DME. On the other hand, it is possible that infrequent injections may not prevent the development of PDR or DME or may not help your vision in the long run. It is also possible that you do not develop PDR or DME, even without injections.

What treatment will I receive if I take part in the study? If you take part in the study, your treatment will be determined by chance. You will receive one of the following two treatment approaches: 1) Periodic anti- VEGF injections from the beginning, 2) Sham injections (Observation) until the diabetic retinopathy has worsened to PDR or DME and then treating with anti-VEGF injections “Sham” means that a real injection is not given. You may not know whether you are receiving a “sham” injection or an injection of drug. How the treatment is selected is described in more detail in the Informed Consent Form.

What is the drug being used in this study?

Eylea® is the anti-VEGF drug being used in this study. It has been approved by the FDA for DME and treatment of diabetic retinopathy in eyes with DME. It has not been approved for the treatment of diabetic retinopathy in eyes without DME. What is involved with injections in the eye? The injections are done through the white part of the eye with a needle which is about the size of a single hair. Before the injection is given, the surface of the white part of the eye is cleaned to prevent infection. Numbing medicine also is administered before the injection to numb the white part of the eye to minimize or eliminate any discomfort from the injection. When the injection is given, you typically will feel a slight pressure but this is usually not very painful because of the tiny size of the needle used. After the injection, you may have slight discomfort for a few days from the medicines used to clean the eye.

What are the possible serious side effects of the injection?

Possible serious side effects due to the injection itself include: (1) an increase in eye pressure, (2) the development of an infection in the eye, called endophthalmitis, which causes severe pain and needs prompt attention, (3) haziness in the lens of the eye, called cataract, (4) separation of the retina from the back of the eye (retinal detachment), and (5) bleeding in the eye. These can be serious but they are very uncommon. Common but less serious side effects of the injection which usually resolve in one to seven days include irritation of the eye, seeing floaters, and blood on the white part of the eye. Additional possible side effects due to the study drugs themselves include: (1) inflammation of the eye and (2) an allergic reaction. There may be a small increased risk of high blood pressure, heart attack, or stroke caused by Eylea®. These side effects occur when similar drugs are given in large doses into the vein to treat cancer. The dose being given in the eye is much smaller so we think that side effects to the body will be very rare if at all, but we cannot be sure at this time.

How long will the study last?

The study will last four years. Follow-up visits are at 1, 2, and 4 months and every 4 months thereafter. More frequent visits may be needed if you develop PDR or DME. What costs will be my responsibility? There may be charges for problems that might develop related to the treatments.

Will I be reimbursed for expenses?

If you take part in the study, you will be provided a $25 gift card for each required completed visit. If you do not complete all of the visits or discontinue the study before it ends, you will receive gift cards only for completed visits.

What do I need to do to participate in the study?

You will be given an Informed Consent Form to read. This document will provide much greater detail about the study. If you would like to consider being in the study, we will first ask you to sign the form so that testing can be done to determine if you likely meet all of the eligibility criteria for the study. It will require two separate visits within one month to determine if you are eligible. If you are eligible, we will again discuss the study and answer any questions you may have before you decide whether or not to enter the study.

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

DRCR Protocol AC

Intravitreous Aflibercept vs. Intravitreous Bevacizumab + Deferred Aflibercept for treatment of Central-Involved Diabetic Macular Edema

A multi-center study being conducted by the Diabetic Retinopathy Clinical Research Network sponsored by the National Institutes of Health, the U.S. Department of Health and Human Services.

General Information for a Patient Who May Want to Be a Participant in this Study

Your eye doctor is taking part in a study being conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net). This Network includes over 100 eye centers in the United States and Canada that specialize in the care of patients with diabetic eye disease.

The study is being funded by the National Eye Institute, which is a part of the National Institutes of Health, a branch of the U.S. Department of Health and Human Services that funds medical research.

Following we will tell you about diabetic macular edema and the treatments that are available as standard of care. Then we will explain what is involved if you want to be part of the study.

If you have diabetic macular edema and think you might be interested in taking part in the study, you will be given a document called an Informed Consent Form, which will provide a written explanation of the study in more detail. Your doctor and her/his staff will discuss the study with you and answer any questions you have. You will be given as much time as you may need to decide if you want to take part in the study.

What is Diabetic Macular Edema?

Diabetic Macular Edema (DME) is the term used for swelling in the small part of the retina used for central vision. This abnormal swelling is due to diabetic damage to the blood vessels. The retina is a thin layer of tissue that lines the back of your eye. It is nourished by blood vessels that may become affected by diabetes. The blood vessels are weekend by diabetes and may become leaky. This causes the retina to become thickened or swollen. Swelling of the central part of the retina can lead to decreased vision.

Interested in this study and ready to enroll?

Click Here

How is DME treated?

In most cases, repeated injections into the eye are given of a drug that blocks a substance called Vascular Endothelial Growth Factor ("anti-VEGF drug"). This is because abnormal levels of VEGF can be produced by a retina affected by diabetes. Anti-VEGF drugs decrease the growth of new blood vessels and prevent leakage of fluid from retinal blood vessels damaged by diabetes.

There are currently three different anti-VEGF drugs that are used as injections in eyes. However, only Avastin® and Eylea®, are being used in this study. A recent survey of eye doctors estimated about 60% of the injections in the U.S. for DME are given with Avastin®, about 25% of the injections given with Eylea®, and about 15% with a third anti-VEGF drug called Lucentis®.

Eylea® is approved by the FDA for DME treatment. Avastin® is approved by the FDA for the treatment of cancer. It is not approved for treating DME. It needs to be specially prepared for injecting in the eye.

Does one of the treatments work better?

Recently, a study was done by the DRCR.net comparing Avastin® and Eylea® for eyes with DME. The study showed that both drugs work very well to reduce DME and improve visual activity. However, when the starting vision was moderately or severly reduced (20/50 or worse), Eylea® was better on average than Avastin® at improving vision. Even though Eylea® was better on average, most people who received Avastin® still had very good results with improvements in vision from decreased swelling of the retina.

So why is Avastin® being used to treat DME more often than Eylea®?

Avastin® is much less expensive than Eylea®. Avastin® costs about $60 per injection compared with about $1,800 per injection Eylea®.

What is the purpose of this study?

The purpose of this study is to find out if starting with Eylea® has better results than starting with the less expensive drug, Avastin®, and only switching to Eylea® if needed.

What treatment will I receive if I take part in the study?

If you take part in the study, your treatment will be determined by chance. This is like flipping a coin to decide which treatment approach you will receive. You will receive either:
1) Eylea® injections from the start OR
2) Avastin® injections to start and switching to Eylea® injections only if needed.

What is involved with injections in the eye?

The injections are done through the white part of the eye with a needle which is about the size of a single hair. Before the injection is given, the surface of the white part of the eye is cleaned to prevent infection. Numbing medicine also is administered before the injection to numb the white part of the eye to minimize or eliminate any discomfort from the injection. When the injection is given, you typically will feel slight pressure but this is usually not very painful because of the tiny size of the needle used. After the injection, you may have slight discomfort for a few days.

What are the possible serious side effects of the injections?

Possible serious side effects due to the injection itself include:
1) an increase in eye pressure,
2) the development of an infection in the eye, called endophthalmitis, which causes severe pain and needs prompt attention,
3) haziness in the lens of the eye, called cataract,
or 4) separation of the retina from the back of the eye (retinal detachment).

These can be serious but they are very uncommon. Common but less serious side effects of the injection which usually resolve in one to seven days include irritation of the eye, seeing floaters, and blood on white part of the eye.

Additional possible side effects due to Eylea® or Avastin® itself include: inflammation of the eye or an allergic reaction. There may be an increased risk of high blood pressure, heart attack, or stroke due to these drugs. These side effects occur when similar drugs are given in large doses into the vein. The dose being given in the eye is much smaller so we think that side effects to the body will be very rare, but we cannot be sure.

How long will the study last?

The study will last two years. During that time, your visit, schedule and treatment will vary. During the first year, you will have follow-up visits every 4 weeks. During the second year, you will have follow-up visits every 4 weeks as long as you need monthly injections and then every 4 - 16 weeks once injections are stopped.

What costs will be my responsibility?

There may be charges for the treatments and office visits that would have been part of your regular eye care if you were not in the study. You and/or your insurance company will be responsible for these charges. There will be no out-of-pocket expenses to you for either the Avastin® or the Eylea®.

Will I be reimbursed for travel expenses?

If you take part in the study, you will be provided a $25 gift or money card for each required completed visit.

What do I need to do to participate in the study?

You will be given an Informed Consent Form to read. If you would like to consider being in the study, we will first ask you to sign that form so that testing can be done to determine if you meet all of the eligibility criteria for the study. If you are eligible, we will again discuss the study and answer any questions you may have before you decide whether or not to enter the study.

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

DRCR Protocol AD

PROMINENT-Eye Evaluating the Effect of PEMAFIBRATE on Diabetic Retinopathy.

What is diabetic retinopathy?

About 8 million people in the U.S. currently have diabetic eye disease, which is called diabetic retinopathy. Diabetic retinopathy is the leading cause of vision loss among working age adults in the United States.

Diabetic retinopathy occurs when there is damage to the blood vessels on the surface of the retina due to high blood sugar (diabetes).

What is the PROMINENT-Eye Study?

The PROMINENT-Eye study is a part of the main PROMINENT study. It will include about 900 adults who are randomized in the PROMINENT study in the USA and Canada. The purpose of the PROMINENT-Eye study is to show if pemafibrate can help reduce the worsening of diabetic retinopathy. A medication similar to pemafibrate has shown that this is possible if the same can be proven with pemafibrate, then this new treatment could be used to help reduce the loss of vision among patients with diabetes worldwide.

Who is conducting the PROMINENT-Eye Study?

This PROMINENT-Eye study is being conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net). This Network includes over 100 eye centers in the United States and Canada that specialize in the care of patients with diabetic retinopathy.

Interested in this study and ready to enroll?

Click Here

The DRCR.net started over 15 years ago and has conducted over 25 studies on diabetic eye disease. The study is being funded by Kowa, Inc. and by the National Eye Institute, which is a part of the National Institutes of Health (NIH).

The NIH is a branch of the U.S. Department of Health and Human Services that funds medical reserarch.

Outline of Study Visits

Screening Visit (Visit 1)

The visit must occur by 3 months after Randomization in PROMINENT.

The eye doctor will check if you are eligible for the sub-study by performing an eye exam, a visual acuity test, and taking two types of images of your eyes.

Follow Up Visits

There will be two follow up visits scheduled after the screening visit.

The eye doctor will perform an eye exam, a visual acuity test, and take two types of images of your eyes.

When will I have my Follow Up Visits?

Two years and four years after the screening visits.

If treatment is planned for one or both of your eyes after the screening visit.

If your participation in the PROMINENT study ends early, before four years have passed.

What can I expect if I participate?

If you choose to participate in the PROMINENT-Eye study, you will be followed for up to four years. There will be three scheduled study visits in this study. Study visits will include a visual acuity test and eye imaging and may include an eye exam. There is no eye treatment in this study.

You will be provided a $50 gift card for each required study visit you complete. These visits will take place at the eye center closest to you, at no cost to you. Participation in this study will not impact your usual eye care.

How do I participate in the PROMINENT-Eye Study?

Your PROMINENT study team will connect you with a participating DRCR.net eye center if you are interested in the PROMINENT-Eye study. The eye center will will explain the potential risks and benefits of taking part in the study.

You do not have to participate in the PROMINENT-Eye study in order to continue in the main PROMINENT study.

You may also contact us directly if you should have any questions.

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

TOPAZ Study Clearside Biomedical

Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, announced the enrollment of the first patient in a Phase 3 clinical trial (“TOPAZ”) of suprachoroidal CLS-TA used with an intravitreally administered anti-VEGF agent (“intravitreal anti-VEGF agent”) for the treatment of macular edema associated with Retinal Vein Occlusion (“RVO”).

Suprachoroidal CLS-TA is Clearside’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or SCS™, which is the space located between the choroid and the outer protective layer of the eye known as the sclera.

What is TOPAZ?

TOPAZ is a multicenter, randomized, masked, controlled trial to assess the safety and efficacy of suprachoroidal CLS-TA used together with one of two intravitreal anti-VEGF agents, Lucentis® (ranibizumab) or Avastin® (bevacizumab) in treatment naïve patients with RVO. Patients in the combination arm of the trial will receive suprachoroidal CLS-TA together with an intravitreal anti-VEGF agent at the beginning of the trial, an intravitreal anti-VEGF agent alone at week 4, and suprachoroidal CLS-TA together with an intravitreal anti-VEGF agent at weeks 12 and 24. Patients in the control arm will receive an intravitreal anti-VEGF agent alone at the beginning of the trial and every four weeks thereafter through week 24. After 24 weeks, patients in both arms will be followed for approximately an additional six months. The primary objective of this trial will be to determine the proportion of patients in each arm with a best corrected visual acuity improvement of at least 15 letters from baseline at eight weeks after initial treatment. Several secondary efficacy and safety endpoints will also be evaluated. Clearside anticipates total enrollment of approximately 460 patients in this Phase 3 trial.

“TOPAZ is our second Phase 3 trial of suprachoroidal CLS-TA with an intravitreal anti-VEGF agent in patients with RVO,” said Daniel H. White, Chief Executive Officer and President of Clearside. “Our first Phase 3 RVO study, called SAPPHIRE, is evaluating suprachoroidal CLS-TA in combination with intravitreal Eylea. Accordingly, if the primary endpoints are met in both the TOPAZ and SAPPHIRE trials, we expect to seek an agnostic label in the United States, where suprachoroidal CLS-TA can be used together with any anti-VEGF agent for the treatment of RVO.”

Clearside also announced that, based on patient enrollment progress, it now expects to report preliminary data from the SAPPHIRE trial in the fourth quarter of 2018 instead of the first quarter of 2019.

Suprachoroidal CLS-TA, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline of treatments for unmet or underserved blinding eye diseases where the pathologies manifest in the retina and the choroid.

RVO shouldn't keep you from what you love.

We are currently conducting a research study for people who have experienced sudden vision loss due to Retinal Vein Occlusion (RVO). Learn how you could participate.

Because of your sudden vision loss, you have been diagnosed with retinal vein occlusion (RVO).

This serious eye condition occurs when a blockage develops in one of the veins that returns blood from your retina. While your vision could return to normal on its own, unfortunately there is also a chance that your vision will not be as strong or clear as it was, due to long-term damage from RVO. Receiving treatment for RVO may help your recovery.

Available treatment options focus on either reducing inflammation that could be blocking the retinal vein, or stopping excess fluid from building up in the eye, both of which are related to RVO. You may have tried one or both of these options, but are still looking for an alternative option.

One option to consider is the TOPAZ study that is evaluating the combined use of an investigational drug for reducing inflammation and two drugs that help reduce excess fluid in the eye. By using these drugs together to treat two different aspects of the condition, doctors believe it might be a more effective way to treat RVO, which could offer a better outcome in restoring damaged vision.

If you are eligible for the TOPAZ study, you will receive injections of one of the two drugs that reduce excess fluid and either the investigational drug or a sham procedure, which simulates an injection. No medication is injected into the eye during a sham procedure.

Interested in this study and ready to enroll?

Click Here

The injections and sham procedures will be administered by the study staff about every 4 weeks for 24 weeks. You may also receive injections of a drug approved to treat RVO, as needed, for another 12 weeks.

The results of this study will provide more information about the investigational drug and whether it could one day be used to help treat RVO.

Who is eligible to participate in the TOPAZ study?

To pre-qualify for this study, you must:

  • Be at least 18 years of age
  • Have been diagnosed with RVO in your eye within 6 months of beginning the study
  • Have not received treatment for RVO.

All study-related visits, tests, and medications will be provided at no cost. In addition, reimbursement for study-related time and travel may be provided.

What will happen during the TOPAZ study?

If you are eligible for this study, you will be randomly assigned (like the flip of a coin) to 1 of 4 treatment groups. Two groups will receive injections of one of the drugs that reduces excess eye fluid and the investigational drug. The other two groups will receive injections of one of the drugs that reduces excess eye fluid and have sham procedures performed. You have an equal chance of being assigned to any of the 4 treatment groups.

You will visit the study clinic about every 4 weeks to receive at least one injection. During your study clinic visits, doctors and the study staff will evaluate your health and progress through various tests and assessments. Your total study participation will last approximately 50 weeks and includes up to 12 study clinic visits.

What are the benefits and risks related to the TOPAZ study?

While it is possible you could benefit from participating in this study, that cannot be guaranteed. It is also possible you could experience a side effect while in this study. The study staff will review the full list of risks and side effects with you before you join the study.

Because research studies can affect your health and safety, you will be monitored while you are in this study. The sponsor of this study was required to design a protocol, which explains all study procedures in detail. An independent review board responsible for participant safety reviewed this protocol and requires that it be followed exactly.

About research studies

Pharmaceutical companies use research studies like the TOPAZ study to learn more about investigational drugs before they are made available to the public. The results of this study will provide more information about the investigational drug being evaluated in this study. By taking part in the TOPAZ study, you will be making an important contribution to retinal vein occlusion (RVO) treatment research.

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

Our Research Team

Dianelis, Alma, Sher-Ami, Enrique: VA
Lora: OCT
Tim and Julie: FA/FP
Sasha: Dr.’s scribe
Elaine: Entering live data, HbA1C, urine lab, sending labs, regulatory paper work and binder, completing queries, assisting in site evaluations, making appointments for patients, assist procedures with doctor.