Participate In A Clinical Trial

Clinical trials are central to medical advancement. They are intended to evaluate the safety and efficacy of new disease prevention, detection, and treatment approaches. Trials also seek novel applications for existing treatments, new drugs, surgical procedures, and devices.

Why Participate In A Clinical Trial?

Participants in clinical trials sign up to potentially receive the most recent treatment for their conditions, to receive additional care and attention from clinical trial staff, and to assist researchers in finding better treatments for future patients. Clinical trials in the United States must meet stringent standards and be registered with the National Institutes of Health.

  • Participation in a clinical trial is free of charge.
  • There is currently no FDA-approved retinal disease (dry AMD) treatment.
  • The patient is a non-responder to the currently approved FDA treatment.
  • Clinical trials provide advanced treatment options that may be superior to the standard of care.
  • Contribute to the advancement of clinical research. Extra care and attention during study visits: ECG, blood work, frequent eye exams: bilateral for most protocols and performed non-protocol at certain visits if not part of the protocol, transportation to and from appointments, dedicated coordinator throughout the study, snacks, coffee, lunch for long study visits, stipend for each completed visit.

Clinical Trials That We Are Currently Enrolling In

Wet AMD (Age-related Macular Degeneration) is a degenerative eye disease that affects the macula, the central part of the retina. It is characterized by the growth of abnormal blood vessels under the retina, which can lead to vision loss if left untreated.

  • Regenexbio RGX-314-2104 Atmosphere – A Phase 2b/3 study evaluating the efficacy of a single administration of RGX-314 Gene Therapy compared to standard of care treatment in patients with wet AMD.
  • Regenexbio RGX-314-2104 Ascent  – A Phase 2b/3 study evaluating the efficacy of a single administration of RGX-314 Gene Therapy compared to standard of care treatment in patients with wet AMD.
  • 4DMT 4D-150-C001 PRISM – A Phase 1/2 study evaluating an intravitreal injection of 4D-150 gene therapy in patients with wet AMD.
  • Ocugenix OCU-10-C-110-CS101 – A Phase 1 study evaluating safety and tolerability of single ascending doses and multiple repeat injections of OCU-10-C-110 for patients with wet AMD.

The majority of macular degeneration cases are categorized as the dry form, indicating the absence of bleeding or leakage in the macula. The primary symptoms of this type of degeneration include blurred vision and blind spots, which gradually progress and can ultimately result in legal blindness. Unfortunately, there is presently no FDA-approved treatment available to manage this condition. Ongoing research efforts are therefore focused on slowing or stopping the progression of the disease, and preventing further vision loss.

  • Aviceda AVD-104-C01 – A single and multiple dose study to evaluate the safety, pharmacokinetics, and treatment effect of intravitreal AVD-104 in patients with geographic atrophy secondary to AMD.

Diabetic retinopathy, which is a complication of diabetes, is the primary cause of vision loss among working-age Americans and is also a common cause of permanent visual impairment in middle-aged individuals. The length of diabetes and poor diabetic control are significant factors that increase the risk of developing diabetic retinopathy. It may be asymptomatic, and is typically detected through routine retinal exams. Damage to the delicate blood vessels in the retina due to diabetes leads to hemorrhages and leakage. Current treatments involve injecting drugs into the eye to minimize blood vessel damage. Ongoing research is focused on developing more long-lasting drugs and treatments that can reduce the severity of diabetic retinopathy and prevent serious complications.

  • DRCR Protocol AF – A randomized clinical trial evaluating fenofibrate for preventing the worsening of diabetic retinopathy.

Chronic leakage of blood vessels in diabetic patients can result in the development of diabetic macular edema, a condition where the retina swells, leading to impaired vision. This is the leading cause of vision loss in patients with diabetic retinopathy, causing a gradual blurring of vision that cannot be corrected with eyeglasses. The condition can be effectively treated with present-day drugs in about 60% of cases, administered through monthly injections directly into the affected eye. Although it commonly occurs in both eyes, it may not affect both eyes simultaneously. Ongoing research efforts are focused on developing more efficient and long-lasting treatments that are better at managing the condition.

  • Genentech GR43828 – A Phase 1 open-label study, evaluating a novel drug administered alone or in combination with standard of care Eylea in patients with diabetic macular edema.
  • Aviceda AVD-104-C301 – A Phase 2 study to evaluate the safety and treatment effect of intravitreal AVD-104 in reducing macular edema associated with diabetic retinopathy.
  • 4DMT 4D-150-C002 SPECTRA – A Phase 2 randomized, active-controlled, double-masked trial of intravitreal 4D-150 gene therapy in adults with diabetic macular edema.
  • DRCR Protocol AN – A Phase 2 evaluation of tonabersat for diabetic macular edema.
  • Unity UBX1325-04 Aspire – A Phase 2b, prospective, multicenter, randomized, double-masked, active-controlled study to assess the efficacy and safety of repeat intravitreal injections of foselutoclax (UBX1325) in patients with diabetic macular edema.

Diabetic Macular Ischemia is a complication of diabetes that affects the blood vessels in the retina, leading to reduced blood flow and oxygen supply to the macula, which can cause vision loss.

  • No enrolling trials at this time.

Macular telangiectasia type 2 is a rare congenital retinal disease that typically affects young adults or those in middle age, resulting in blurred vision in one or both eyes. Presently, there are no FDA-approved treatments available for managing this condition. However, we are currently enrolling patients in a nationwide registry study aimed at gathering data on this rare disease to support future clinical trials and the development of new treatments. Participation in the registry involves a one-time in-office visit, which is free of charge to the patient. Benefits of participation include confirmation of diagnosis by an independent central reader, and staying up-to-date on future interventional clinical trials.

  • No enrolling trials at this time.
Epiretinal Membrane is a thin layer of tissue that forms on the surface of the retina and can cause visual distortion, such as wavy or blurred vision, or a partial loss of vision.
  • DRCR Protocol AM – Randomized clinical trial to compare immediate v. deferred surgery (vitrectomy) for epiretinal membrane. This is a unique study examining if treatment with surgery early vs waiting until the epiretinal membrane is worse would provide the best outcome.

Retinal vein occlusions are the third most prevalent retinal disease, often resulting in vision loss. They are commonly associated with the aging of blood vessels, which can be compounded by underlying conditions like hypertension and diabetes. Moreover, glaucoma can also increase the risk of developing this condition. Present-day treatments are effective in improving vision in around 75% of cases, and comprise drugs that are directly injected into the eye and laser surgery. Ongoing research is now focused on developing more efficient and long-lasting drugs, with the aim of improving the outcomes of treatment.

  • No enrolling trials at this time.

More clinical trials to come!

  • Bergundy BP41670 – A three-part, Phase 1 study to investigate the safety, tolerability, pharmacokinetics, and efficacy of zifibancimig following multiple ascending intravitreal doses and continuous delivery from the port delivery in patients with wet AMD.

Find Out if You Are Eligible to Participate in a clinical trial

Call us at 317-660-1605 or fill out this form and we will get back with you:

Testimonials

Bette Fortino

“Participation in a clinical study was a very difficult decision for me to make.

After much deliberation, I thought of the fact that my grandmother, my mother, many relatives, and I all had MD. I have three daughters, and seven grandchildren. My participation in the study could be beneficial to them in the future. The decision was made!

The clinical lasted several months.. The staff was outstanding, and the results proved to be excellent for me, and I would do it again”

Darlene S.

“I highly recommend Retina Partners Midwest. I am so glad that I live here in Indianapolis and trials here are available for people who are looking for better sight and treatments.

I never felt like I was a guinea pig. I knew I was in good hands. I had heard a lot of good things about Dr. Maturi.”

Sandy P.

“They have always made me feel like a true person, they’re interested in me, personally, not just in the results.

Everyone I have met have always been very nice. They easily establish a rapport with you, They seem to be interested in you as a person.

I have always had very good care, very pleased with my doctor, Dr. Maturi, and very pleased with all of his staff.”

Jeffrey H.

“Lorrain, Dr. Maturi, and Dr. Saxe were great to work with. Lorrain always has answers to the questions I had. You won’t find any better staff and doctors anywhere.”

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