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

NCT04895293 | Completed Phase 1 Results FDA Drug

• 1 other identifier: RKM-011
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Macular Edema

  Central subfield thickness on optical coherence tomography

  3 months

Secondary Outcomes (1)

• Visual Acuity

  3 Months

Study Arms (1)

RBM-007 Injectable Solution - 2.0 mg

EXPERIMENTAL

Single intravitreal injection in study eye

Drug: RBM-007 Injectable Solution

Interventions

RBM-007 Injectable Solution DRUG

Sterile solution

RBM-007 Injectable Solution - 2.0 mg

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

• 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.
• 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).

Sponsors & Collaborators

• Maturi, Raj K., M.D., P.C.: lead

Study Sites (1)

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Raj K. Maturi, M.D.
• Organization: Midwest Eye Institute

maturi.md@midwesteye.com

317-817-1423

Study Officials

• Raj K. Maturi, M.D.

  Midwest Eye Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: All subjects receive the study treatment

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: June 15, 2021
• Primary Completion: February 8, 2022
• Study Completion: March 4, 2022
• Last Updated: April 12, 2023
• Results First Posted: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)