Clinical Trials

What is a clinical trial?

Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted. These allow doctors to examine the benefits and risks of using these drugs. Clinical trials are designed to find safe treatments that work in people and new ways to improve health.

Why you should consider to participate in a clinical trial?

In many different situations, clinical trials offer cutting edge treatment other wise not available to patients. A patient could benefit from his participation, since in many diseases, like dry macular degeneration, there is no other available treatment. Patients can also benefit since normally all procedures are cover by the pharmaceutical company or sponsor, and can have access to different modalities of treatment. Patient will contribute to enhance the future treatments. Will also benefit in the knowledge acquisition regarding a specific disease.

How patients are protected during the participation in a clinical trial?

Patients are protected by the Food and Drug Administration (FDA), The National Institute of Health (NIH) and Independent Review Boards. These identities oversee all research to protect the rights and maintain welfare of all study participants.

If you will like more information please visit the following websites:

Current Protocols Enrolling at our Practice:

  1. DRCR (Diabetic Retinopathy Clinical Research Network) Protocol S Prompt PRP Versus Intravitreal Ranibizumab with Deferred PRP for Proliferative Diabetic Retinopathy
  2. DRCR Protocol R A Phase II Evaluation of Topical NSAID in Eyes with Non Central Involved Diabetic Macular Edema.
  3. DRCR Protocol T Intravitreal Bevacizumab Compared with Intravitreal Ranibizumab for Diabetic Macular Edema
  4. A Phase 2a Multicenter, Masked, Randomized, Comparator-Controlled Study Evaluating Isonep, as either Monotherapy or Adjunctive Therapy to Lucentis or Avastin Versus Lucentis or Avastin Alone for the Treatment of Subjects with Choroidal Neovascularization Secondary to Age Related Macular Degeneration.
  5. A Double-Masked, Randomized, Active-Controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI]) in Patients with Macular Edema Secondary to Branch Retinal Vein Occlusion