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

Age Related Macular Degeneration Clinical Trial

— TEMPURA  

Official title:

Evaluation of RBM-007 in Subjects With Treatment naïve Exudative Age-related Macular Degeneration (AMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04895293
• Other study ID #: RKM-011
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 15, 2021
• Est. completion date: March 4, 2022

Study information

• Verified date: March 2023
• Source: Maturi, Raj K., M.D., P.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 4, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• RBM-007 Injectable Solution
Sterile solution

Locations

Country	Name	City	State
United States	Midwest Eye Institute	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Maturi, Raj K., M.D., P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular Edema	Central subfield thickness on optical coherence tomography	3 months
Secondary	Visual Acuity	Change from Baseline in Best Corrected Visual Acuity	3 Months