Phase 2
N=5
RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration
Age Related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT04895293 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Macular Edema — 416 Microns
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RBM-007 Injectable Solution (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Maturi, Raj K., M.D., P.C.
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Macular Edema |
416 | — |
| SECONDARY Visual Acuity |
60 | — |
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.
Eligibility Criteria
Inclusion Criteria
- General Inclusion Criteria:
- 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.
- Ocular Inclusion Criteria:
- 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.
Exclusion Criteria
- General Exclusion Criteria:
- 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.
- Ocular Exclusion Criteria:
- 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).
Data sourced from ClinicalTrials.gov (NCT04895293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.