Diabetic Retinopathy
DR:EAM-OTT166-201 (Sponsor: Ocuterra)
2022-Present
Office: Teaneck
NCT Number: NCT05409235
This randomized, double-masked, vehicle controlled, phase 2 study will evaluate the safety and efficacy of OTT166 ophthalmic solution in participants with diabetic retinopathy and select an optimum dosing regimen for Phase 3 pivotal trials. Approximately 210 participants diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) and who are treatment naïve (ie, no prior anti-vascular endothelial growth factor [anti-VEGF] or laser [focal, grid, pan-retinal photocoagulation (PRP)] administered) and participants who do not have center-involved diabetic macular edema (CI-DME) will be randomized into the following groups:
OTT166 Cohort 1, OTT166 Cohort 2, Vehicle control Cohort 1, Vehicle control Cohort 2.
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Altitude-RGX-314-2202 (Sponsor: RegenXBio)
2021-Present
Office: Teaneck
NCT Number: NCT04567550
This phase 2, randomized, dose-escalation study is designed to evaluate the efficacy, safety and tolerability of RGX-314 gene therapy in subjects with DR without center-involved diabetic macular edema (CI-DME). Approximately 100 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 5 cohorts. Participants will be randomized in Cohorts 1, 2, 4 and 5 to receive RGX-314 or to be observed, and participants enrolled in Cohorts 3 will receive RGX-314. Cohort 1 will evaluate RGX-314 Dose 1, Cohorts 2 and 3 will evaluate RGX-314 Dose 2, Cohorts 4 and 5 will evaluate RGX-314 Dose 3. Following SCS RGX-314 administration, participants in Cohorts 4 and 5 will receive a protocol-mandated post-procedure steroid regimen for 7 weeks. Participants who are randomized to be observed in Cohorts 1, 2, 4 and 5 will be offered RGX-314 after completing the study. Efficacy will be the primary focus of the study. Participants will be evaluated for safety and tolerability of RGX-314 throughout the study.
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Wet AMD
LUNA(Sponsor: Adverum)
2022-Present
Office: Teaneck
NCT Number: NCT05536973
This Phase 2, multi-center, randomized, double-masked, parallel group study is designed to evaluate the safety, tolerability, and efficacy of a single IVT injection of ADVM-022 at one of two dose levels (2 × 10^11 vg/eye [2E11] or 6 × 10^10 vg/eye [6E10]) accompanied by one of four prophylactic corticosteroid treatment regimens. Approximately, 72 anti-VEGF treatment-experienced study participants meeting the eligibility criteria will be randomized equally between the 2E11 vg/eye and 6E10 vg/eye ADVM-022 doses across four prophylactic corticosteroid regimens, and only one eye per study participant will be selected as the study eye. Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.
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Geographic Atrophy
Onward-ALXN2040-GA-201 (Sponsor: Alexion)
2022-Present
Office: Teaneck
NCT Number: NCT05019521
This is a dose finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD. The study consists of a Screening Period of up to 6 weeks, a 104-week masked Treatment Period, followed by a 30-day Follow-up after the last dose. This study will have 4 treatments arms: 100 milligrams (mg) twice daily (bid), 200 mg bid, 400 mg once daily (qd), and matching placebo.
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Concerto- CDV-SNG-21-001 (Sponsor: Samsara)
In Conjunction with Dr. Miller
2022-Present
Office: Teaneck
NCT Number: NCT05438732
The objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD). Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study, including assessment of their best-corrected distance- and near- visual acuity with and without refraction, and also when using an external telescope simulator (ETS) to determine if they are likely to benefit from receiving the IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. Following implantation, patients will return for 5 post-operative follow-up visits over a period of approximately 12 months. Additionally, patients will have up to 12 rehabilitation/training visits with a low vision specialist.
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