Research & Trials
Explore comprehensive insights into eye health, clinical research, and treatment options. Discover how participating in trials can lead to advancements in vision care and help maintain eye wellness.
CRMD’s research program is one of the largest in the country for a community-based practice and rivals those of some of the largest academic medical centers.
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. Clinical trials used in drug development are sometimes described by phase. These phases are defined By the Food and Drug Administration – each phase is designed to answer a separate research question.
- Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
- Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
Currently Enrolling
Wet Aged Related Macular Degeneration (WAMD)
- NCT05769153: Protocol RTE888-E001 (NOVA1)
A Phase 1/2 Two-Stage Dose Escalation and Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety, Preliminary Treatment Effects, and Durability of AR14034 Sustained Release Implant Compared to Intravitreal Anti-vascular Endothelial Growth Factor Treatment (VGEF) with Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD). - Protocol KLRS-100 (Kalaris Therapeutics)
A Phase 1/2 Clinical Trial to Establish Safety, Dose Range, and Pharmacokinetic Profile of Intravitreal Injection of TH103 in Patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD) and a Dose-Finding, Masked, Comparative Safety and Preliminary Efficacy Study of TH103 in patient with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME) and/or Retinal Vein Occlusion (RVO).
Non-proliferative diabetic retinopathy (NPDR)
- NCT06321302: Protocol 1436-0007 (Crimson)
A Multicentre, Randomised, Sham-controlled (and Active Controlled in the USA), Double-masked, 72-week Trial to Study the Safety, Tolerability, Pharmacokinetics, and Efficacy of 3 Dosing Regimens of Intravitreal BI 764524 in Patients With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Geographic Atrophy (GA)
- NCT06541704: Protocol R3918-AMD-2326 (Sienna)
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination with Cemdisiran or Cemdisiran Alone in Participants with Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).
Diabetic Macular Edema (DME)
- NCT06962839: Protocol 1485-0018 (Thulite)
A Randomized, Double-Masked, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral BI 1815368 in Participants with Centre-involved Diabetic Macular Edema (DME) for 48 Weeks of Treatment.
Closed To Enrollment
- Opthea – A 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) (Phase 2).
ClinicalTrials.gov Identifier: NCT03345082
- Kalvista – A randomized sham-controlled double-masked phase 2a study of the efficacy, safety and tolerability of the intravitreal plasma kallikrein inhibitor, KVD001, in subjects with center-involving diabetic macular edema who have had prior anti-vascular endothelial growth factor treatment.
ClinicalTrials.gov identifier: NCT03466099
- Aldeyra ADX-102 – A Phase 3, Randomized, Double-masked, Vehicle-controlled Trial to Evaluate the Safety and Efficacy of ADX-102 Ophthalmic Solution in Subjects With Non-infectious Anterior-uveitis.
ClinicalTrials.gov Identifier: NCT03131154
- Opthotech 2003 – A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura® (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02686658
- Chengdu Panda – The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD. (Phase 3)
ClinicalTrials.gov Identifier: NCT03577899
- Aerie Pharmaceuticals – This study will evaluate the safety, tolerability and efficacy of AR-1105 (dexamethasone implant) for the treatment of macular edema (ME) due to retinal vein occlusion (RVO). A more durable intravitreal implant containing a low dose of dexamethasone may result in less frequent retreatments, and potentially lower the incidence of steroid-related side effects without compromising efficacy. (Phase 2)
ClinicalTrials.gov Identifier: NCT03739593
- ThromboGenics/Oxurion Pharmaceuticals – A Phase 1, Open-label, Multicenter, Dose Escalation Study to Evaluate the Safety of a Single Intravitreal Injection of THR-687 for the Treatment of Diabetic Macular Edema (DME)
ClinicalTrials.gov Identifier: NCT03739593
- Graybug GBV-102-002 – Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated Intravitreal injections of 3 dose levels of GB 102 compared with Aflibercept.
Clinicaltrials.gov Identifier: NCT03953079
- Kingfisher – A 12-Month, 2-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema.
ClinicalTrials.gov Identifier: NCT03917472
- Outlook Therapeutics ONS-5010-00 – A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration.
Clinicaltrials.gov Identifier: NCT03834753
- Mylan – A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema.
ClinicalTrials.gov Identifier: NCT03610646
- Apellis Pharmaceuticals – 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.
Clinicaltrials.gov Identifier: NCT03525613
- Xbrane XBR-1001 – Phase 3, double-blind, parallel group, multicenter study to compare the efficacy and safety of Xlucane versus Lucentis® in patients with Neovascular Age-Related Macular Degeneration.
Clinicaltrials.gov Identifier: NCT03805100
- SCD411 – A Phase III Randomized, Double-Masked, Parallel Group, Multicenter Study to Compare the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity Between SCD411 and Eylea® in Subjects With Neovascular Age-related Macular Degeneration.
Clinicaltrials.gov Identifier: NCT04480463
- Talon – A 64-week, Two-arm, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen in Patients With Neovascular Age related Macular Degeneration.
Clinicaltrials.gov Identifier: NCT04005352
- Stealth Spiam – A Phase 2 Randomized, Double-Masked, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Elamipretide in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration.
Clinicaltrials.gov Identifier: NCT03891875
- Alkeus SAGA – A Phase 2/3 Multicenter, Randomized, Double-masked, Parallel-group, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics, Tolerability, and Efficacy of ALK-001 in Geographic Atrophy Secondary to Age-related Macular Degeneration.
Clinicaltrials.gov Identifier: NCT03845582
- Unity-A – Phase 1, Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of a Single Intravitreal Injection of UBX1325 in Patients With Diabetic Macular Edema.
Clinicaltrials.gov Identifier: NCT04537884
- Regeneron 1934 – A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema.
Clinicaltrials.gov Identifier: NCT04429503
- Outlook Therapeutics ONS – A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders.
Clinicaltrials.gov Identifier: NCT04516278
- EYE-RES-102 – A Randomized, Double-Masked, Multi-Center, 3-Arm Pivotal Phase 2/3 Study to Evaluate The Efficacy and Safety of Intravitreal EYE103 Compared With Intravitreal Ranibizumab (0.5mg) in Participants With Diabetic Macular Edema
Clinicaltrials.gov Identifier: NCT06571045
- Kyowa – A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Diabetic Macular Edema
Clinicaltrials.gov Identifier: NCT06116890
- GLOW2 – anging A Prospective, Randomized, Double-masked, Sham-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer in Participants With Moderately Severe to Severe Non-Proliferative Diabetic Retinopathy (NPDR)
ClinicalTrials.gov Identifier: NCT06270836
- Pregonda – A Phase 1, Multipart, MultiCenter Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of R07497372 Following Intravitreal Administration in Participants With Diabetic Macular Edema (DME) (Part 1 Non-Randomized, Open-Label, Multiple Ascending Dose; Part 2 Randomized, Double-Masked)
ClinicalTrials.gov Identifier: NCT06847854
- Ollin – A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Two Different Formulations of Intravitreal OLN324 in Adult Participants With Either Neovascular (Wet) Age-Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)
ClinicalTrials.gov Identifier: Protocol OLN324-CP-01
- GLOW2 – A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Three-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer and Tabirafusp Tedromer Compared with Intravitreal Aflibercept in Participants with Neovascular (Wet) Age-Related Macular Degeneration (AMD)
ClinicalTrials.gov Identifier: NCT06556368
- RGX – A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With Age-Related Macular Degeneration (AMD)
ClinicalTrials.gov Identifier: NCT05407636
- Lugano – A Phase 3 study of EYP-1901, a tyrosine kinase inhibitor (TKI), compared to Aflibercept in Participants with Neovascular (Wet) Age-Related Macular Degeneration (AMD) and Non-Proliferative Diabetic Retinopathy (NPDR)
ClinicalTrials.gov Identifier: Protocol EYP-1901-301
- JADE – A Phase 3 , Randomized, Double-Masked, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy and Safety of BI 1584862 in Participants with Geographic Atrophy (GA).
ClinicalTrials.gov Identifier: NCT06769048
- Cognition – A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants with Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).
ClinicalTrials.gov Identifier: NCT05893537