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

NCT ID: NCT04895293

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2022-03-04

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.

Conditions

Age Related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RBM-007 Injectable Solution - 2.0 mg

Single intravitreal injection in study eye

Group Type: EXPERIMENTAL

RBM-007 Injectable Solution

Intervention Type: DRUG

Sterile solution

Interventions

RBM-007 Injectable Solution

Sterile solution

Intervention Type: DRUG

Eligibility Criteria

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.

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

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.

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).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raj K. Maturi, M.D.

Role: STUDY_CHAIR

Midwest Eye Institute

Locations

Midwest Eye Institute

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RKM-011

Identifier Type: -

Identifier Source: org_study_id