Clinical Trials in the University of Louisville Department of Ophthalmology & Visual Sciences

Advancing Our Understanding of Eye Diseases and How to Treat Them

Clinical trials in the University of Louisville Department of Ophthalmology & Visual Sciences are offering patients and doctors the opportunity to participate in potentially groundbreaking therapies and procedures and advance the field of ophthalmological research. We’re assessing new drugs for approval. Evaluating new instruments and techniques. We’re doing the clinical trials that will change the way doctors view and treat eye diseases in the future.

The University of Louisville’s status as an academic medical center means we are commonly involved in multi-center clinical trials often sponsored by the National Institutes of Health. The Department of Ophthalmology’s specialized equipment and photographic capabilities give us the resources to participate in difficult trials that require very high technical evaluation.

We are always looking for the help of volunteer patients interested in advancing the understanding of eye diseases. The department regularly has several trials in progress.

Current Open Ophthalmology Trials at the University of Louisville

Impact of Cataract Surgery on the Foveal Avascular Zone

Investigators:  M. Adhi MD and D. Sigford, MD – Purpose: Evaluate changes to the FAZ after cataract surgery  Ongoing.

Allergan Sequoia Study

Investigators:  C. Barr MD Purpose: A safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration Ongoing.

Computer-aided Diagnosis of Diabetic Retinopathy using Optical Coherence Tomography Angiography

Investigators:  H. Sandhu Purpose: To quantify various features of the OCTA in patients with any level of diabetic retinopathy and DM without DR in order to correlate them with disease severity, and ultimately to design a computer algorithm to automate diagnosis based on OCTA  Ongoing.

Capillary Non-Perfusion in Retinal Vein Occlusion

Investigators:  R. Sophie MD and D. Signford, MD  Purpose:  Evaluate changes in capillary non-perfusion via OCTA in RVO  Ongoing.

Optical Coherence Tomography Angiography in Pediatric Sickle Cell Disease

Investigators:  J. Adeniran, MD, B. Mueller, DO, A Ramasubramanian. Purpose: To use OCT-angiography to detect subtle changes in the macula in patients with known sickle cell retinopathy and assess differences with and without history of hydroxurea exposure. Ongoing.

Novartis Rainbow Study

Investigators:  C. Barr, MD, HJ Kaplan, MD, D Signford, MD. Purpose: A randomized, controlled study evaluating the efficacy and safety of ranibizumab compared with laser therapy for the treatment of infants born prematurely with retinopathy of prematurity.   Ongoing.

Biomedical Assay (BMA) for Rapid Detection of Pathogens in Intraocular Iinfection

Investigator:  W. Wang, MD, M O’Toole, S. Mendis, H Kaplan, MD.  Purpose: Use of a new platform Incorporating a sandwich bioassay onto a single-mode, electro-active,integrated optical waveguide (EA-IOW) to detect pathogens in ocular infection.  Ongoing.

Etiology of Idiopathic Intraocular inflammation

Investigators:  W. Wang, MD, H. Sandhu, MD, H Kaplan, MD. Purpose: Use of PCR to determine potential infectious pathogens in idiopathic uveitis.  Ongoing.

Occult Choroiditis and Retinal Vasculitis in Patients with Anterior or Intermediate Uveitis

 Investigators:  H. Sanhu, MD, W. Wang, MD, H Kaplan, MD.  Purpose: To document the prevalence and severity of occult choroiditis or retinal vasculitis in patients presenting with just anterior and/or intermediate uveitis on clinical exam with the use of FA/ICG and OCTA   Ongoing.

Periocular and Intravitreal Corticosteroids for Uveitic Macular Edema (POINT) Trial

Investigator:  H Sanhu, MD.  Purpose: To compare the efficacy and adverse effects of three common modes of delivering steroids for uveitic macular edema, i.e. intravitreal triamcinolone vs. periocular triamcinolone vs. ozurdex.  Ongoing.

Pediatric Glaucoma Study - Allergan

Sponsored by Allergan Pharmacuticals. Evaluating the safety and IOP-lowering effect of once-daily bimatoprost PF compared to twice-daily timolol in pediatric patients with glaucoma. Ongoing.

Growth and Retinopathy of Prematurity - G-ROP

Sponsored by the National Eye Institute. Retrospective study to develop a prognostic model that includes postnatal weight gain, birth weight, and gestational age at birth to predict infants who are likely to develop severe ROP. Ongoing.

Comparison of Age-related Macular Degeneration Treatment Trials: Lucentis-Avastin Trial

pLucentis-Avastin Trial. Sponsored by the National Eye Institute (NEI). Compares two drug treatments for neovascular “wet” AMD for their effects on vision and for safety. No longer enrolling patients.

Study of the Pathogenesis of Retinal Degeneration

Sponsored by the Robert Rounsavall, Jr. Family Foundation. Examining the possibility that genetic patterns exist among people with Age-related Macular Degeneration (AMD) and other types of retinal degeneration, opening the possibility of finding genes connected with those diseases, their exact causes, and perhaps the ability to prevent some types of retinal degeneration altogether. Ongoing.

Telemedicine Approaches to Evaluating Acute-phase Retinopathy of Prematurity – e-ROP

Sponsored by the National Eye Institute. Evaluating a remote imaging system for babies that are at risk for developing sight-threatening ROP and are in need of a diagnostic evaluation by an ophthalmologist experienced in ROP. Ongoing.

MaculaRisk Genetic Test (Age-related Macular Degeneration Genetic Test)

Identifying individuals who have inherited the disease-causing genes for Age-related Macular Degeneration. Ongoing.

For more information about participating in research at the University of Louisville, please CLICK HERE. You can also contact our Clinical Research Coordinator, Michelle Bottoroff, at 502-852-7387 or email

Understanding Clinical Trials

Choosing to participate in a clinical trial is an important decision. It’s always helpful to discuss your potential participation with your physician, family members, and friends to determine what is right for you.

Clinical trials can be the best way for participants to:

  • Actively play a role in the healthcare they receive
  • Take part in the latest research treatments before they are widely available to other patients
  • Contribute to medical research that may help others

Too often, the myths about clinical trials get more attention than the facts. Here’s the truth behind some of the most common misconceptions:

  • Clinical trials are not just an option used as a last resort
  • Trial participants are not “guinea pigs” for testing drugs
  • Clinical trials are not just for sick patients—they’re for healthy patients, too

It’s important to note that the ethical and legal codes that apply to medical practice apply to clinical trials as well. Also, clinical trials in the University of Louisville Department of Ophthalmology & Visual Sciences are carefully regulated with built in safeguards to protect participants.

If you have further questions about clinical trials, please visit, a service of the U.S. National Institutes of Health. There you’ll find extensive information about the clinical trials process, including more on the benefits and potential risks.