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.
Wet Age-Related Macular Degeneration
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
Amgen – Phase 3, double-masked, randomized study of ABP 938 Efficacy and Safety Compared to Aflibercept (Eylea) in Subjects with Neovascular Age-related Macular Degeneration.
Clinicaltrials.gov Identifier: NCT04270747
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
Ionis Pharmaceuticals – A Phase 2, Randomized Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration.
Clinicaltrials.gov Identifier: NCT03815825
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
Boehringer Ingelheim – The main objective is to investigate ocular and systemic safety and tolerability as well as pharmacokinetics of single intravitreal administration of BI 754132.
Clinicaltrials.gov Identifier: NCT04002310
Diabetic Macular Edema
Kalahari – A Phase 2, Randomized, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME).
Clinicaltrials.gov Identifier: NCT04527107
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
Branch Retinal Vein Occlusion
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
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