Clinical Trials

Clinical trials are a necessary part of the process of developing new approaches to treating retinal conditions and help us understand retinal diseases more thoroughly. The specific trials we are conducting change regularly, but are all focused on optimizing outcomes for patients with retinal diseases. There are many potential benefits to participating in a clinical trial, including helping to advance the field of retinal diseases which include the most common causes of blindness in the USA and most developed countries around the world. Each clinical study has specific criteria that participants must meet. If you’re interested in participating in a clinical trial, please ask your doctor.

 

Actively Enrolling Trials

 

If you would like more information about one of our studies please e-mail [email protected]com or call 713-524-3434.

 

Wet Age-Related Macular Degeneration

NCT03211234: 36-002/AVANTE

A Phase II, Multi-Center, Randomized, Double Masked and Active Controlled Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in combination with Lucentis® Compared to Lucentis® Monotherapy in Subjects with Wet AMD

 

NCT unavailable: ADVERUM

Dose-ranging study of intravitreal OPT-302 in combination with ranibizumab, compared with ranibizumab alone, in participants with neovascular age-related macular degeneration (wet AMD)

 

NCT03150589: SB11-G31-AMD

A Phase III Randomized, Double-masked, Parallel Group, Multicenter Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB11 and Lucentis® in Subjects With Neovascular Age-related Macular Degeneration

 

NCT03345082: OPT-302-1002

A Phase II Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration

 

NCT03066258: RGX-314-001

A Phase I Open-label, Multiple-cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Gene Therapy With RGX-314 in Subjects With Neovascular Age-Related Macular Degeneration

 

Dry Age-Related Macular Degeneration

NCT03525600: APL2-303/Derby

A Phase III, Multi-Center, Randomized, Double-Masked, Sham Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

 

NCT03525613: APL2-304/Oaks

A Phase III, Multi-Center, Randomized, Double-Masked, Sham Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

 

Diabetic Macular Edema

NCT03481634: CRTH258B2301/KESTREL

A Phase 3, Three-Arm, Randomized, Double-Masked, Multicenter Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to DME

 

NCT03511898: THR-149-001

A Phase 1, open-label, multicenter, dose escalation study to evaluate the safety of a single intravitreal injection of THR-149 for the treatment of diabetic macular edema (DME)

 

NCT03397264: OPT-302-1003

A Phase Ib/IIa Study of OPT-302 in Combination with Aflibercept for Persistent Central-Involved Diabetic Macular Edema

 

NCT03321513: DRCR.net Protocol AC

A Phase III Randomized Trial of Intravitreal Aflibercept Versus Intravitreal Bevacizumab + Deferred Aflibercept for Treatment of Central-Involved Diabetic Macular Edema

 

Diabetic Retinopathy

NCT03531294: PRIME

A Phase II Randomized, Open Label Study to Evaluate Safety of Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement

 

NCT03238963: ROBIN

A Phase IIa Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Orally Administered BI 1467335 for 12 Weeks with a 12-Week Follow Up Period in Patients with Non-Proliferative Diabetic Retinopathy without center-involved Diabetic Macular Edema

 

Telangiectasia

NCT unavailable: Mactel Registry

Registry for Upcoming Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus® implants in Macular Telangiectasia Type 2

 

Retinal Vein Occlusion

NCT03203447: TOPAZ

Phase III, Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Anti-VEGF Agent in Subjects With Retinal Vein Occlusion

 

Uveitis

NCT02931175: ACTHAR-01

A Phase II Open-label, Multi-center, Randomized, Study to Evaluate the Safety and Tolerability of 2 Different Dose Regimens of Adrenocorticotropic Hormone (ACTH) Gel Administered by Subcutaneous (SC) Injection in Patients with Non-Infectious Posterior, Intermediate, or Panuveitis

 

NCT03131154: ADX-102-UV-005

A Phase III Randomized, Double-Masked, Vehicle-Controlled Trial to Evaluate the Safety and Efficacy of ADX-102 Ophthalmic Solution in Subjects with Non-Infectious Anterior-Uveitis

 

NCT02623426: MERIT

A Phase III Study to Compare Efficacy and Safety of Intravitreal Methotrexate, Intravitreal Ranibizumab, and the Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema Persisting or Reoccurring After an Intravitreal Corticosteroid Injection

 

Nevus/Melanoma

NCT03052127: AU-011-101

A Phase Ib/II Open-Label, Ascending Single & Repeat Dose Clinical Trial Designed to Evaluate the Safety & Preliminary Efficacy of Light-Activated AU-011-101 for the Treatment of Subjects with Small to Medium (2.0mm-3.4mm thickness) Primary Choroidal Melanoma

 

NCT01925599: BAP101

Identification of Germline BAP1 Mutation In Subjects With Choroidal Nevi or Uveal Melanoma

 

Radiation Retinopathy

NCT03085784: ARRT

A Phase II Trial to Assess the Safety and Efficacy of 2mg Intravitreal Aflibercept Injection for the Treatment of Radiation Retinopathy, Including Maculopathy and Optic Neuropathy