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Phase 2 N=5 Treatment

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

Age Related Macular Degeneration

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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