RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration (TEMPURA)

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

Status and phase: Completed; Phase 2; Phase 1

Conditions: Age Related Macular Degeneration

Treatments: Drug: RBM-007 Injectable Solution

Study type: Interventional

Identifiers

NCT04895293

RKM-011

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

RBM-007 Injectable Solution - 2.0 mg

Experimental group

Description:

Single intravitreal injection in study eye

Treatment:

Drug: RBM-007 Injectable Solution