RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration

Completed · Phase 1/Phase 2

Conditions studied: Age Related Macular Degeneration

In brief

This study is a single-center, open label, 4-month study, designed to evaluate the safety and treatment efficacy of RBM-007 in patients with intraretinal or subretinal edema due to previously untreated neovascular AMD. Up to 5 subjects will be randomized to receive study medication. Study treatment will be administered by intravitreal injections.

Key facts

Study ID

NCT04895293

Run by

Maturi, Raj K., M.D., P.C.

People needed

5

Starts

2021-06-15

Expected to finish

2022-03-04

Last updated by the study team

2023-04-12

Who can join

Age: 50 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• General Inclusion Criteria:
• Male or female patients, 50 years of age or older at baseline
• Patient has completed/signed an informed consent prior to any study-related procedures and is able to follow study instructions and likely to complete all required visits.
• Ocular Inclusion Criteria:
• Best Corrected Visual Acuity (BCVA) 5 - 73 ETDRS letters (20/800-20/40 Snellen equivalent), inclusive, in study eye
• Presence of choroidal neovascularization secondary to AMD
• Clear ocular media and adequate pupil dilation to permit good quality photographic imaging.

You may not qualify if…

• General Exclusion Criteria:
• Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
• History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator.
• Participation in any investigational drug or device study within 30 days prior to baseline
• History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.
• Ocular Exclusion Criteria:
• Active ocular or periocular infections, malignancy
• Aphakia
• History of pars plana vitrectomy in the study eye
• History of major ophthalmic surgery in the past 3 months in the study eye, or minor surgery in the past 30 days
• History of significant ocular disease other than exudative AMD that may confound results
• Uncontrolled glaucoma (defined as intraocular pressure >21mm Hg despite treatment with ocular hypotensive medications at baseline).

Where it is running

• Midwest Eye Institute — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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