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

Phase 1

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: RBM-007 Injectable Solution

• Registration Number: NCT04895293
• Lead Sponsor: Maturi, Raj K., M.D., P.C.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-20
• Study Start: 2021-06-15
• Primary Completion: 2022-02-08
• Study Completion: 2022-03-04
• Status Verified: 2023-03
• Results First Submitted: 2023-03-20
• Results First Submitted QC: 2023-03-20
• Last Update Submitted: 2023-03-20
• Results First Posted: 2023-04-12
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• General Inclusion Criteria:

1. Male or female patients, 50 years of age or older at baseline

2. 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:

3. Best Corrected Visual Acuity (BCVA) 5 - 73 ETDRS letters (20/800-20/40 Snellen equivalent), inclusive, in study eye

4. Presence of choroidal neovascularization secondary to AMD

5. Clear ocular media and adequate pupil dilation to permit good quality photographic imaging.

Exclusion Criteria

• General Exclusion Criteria:

1. Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.

2. History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator.

3. Participation in any investigational drug or device study within 30 days prior to baseline

4. 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:

5. Active ocular or periocular infections, malignancy

6. Aphakia

7. History of pars plana vitrectomy in the study eye

8. History of major ophthalmic surgery in the past 3 months in the study eye, or minor surgery in the past 30 days

9. History of significant ocular disease other than exudative AMD that may confound results

10. Uncontrolled glaucoma (defined as intraocular pressure >21mm Hg despite treatment with ocular hypotensive medications at baseline).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RBM-007 Injectable Solution - 2.0 mg	RBM-007 Injectable Solution	Single intravitreal injection in study eye

Primary Outcome Measures

Name	Time	Method
Macular Edema	3 months	Central subfield thickness on optical coherence tomography

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	3 Months	Change from Baseline in Best Corrected Visual Acuity

Trial Locations

Locations (1)

Midwest Eye Institute; 🇺🇸 Indianapolis, Indiana, United States