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

Sponsor
Maturi, Raj K., M.D., P.C. (Other)
Overall Status
Completed
CT.gov ID
NCT04895293
Collaborator
(none)
5
Enrollment
1
Location
1
Arm
8.6
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: RBM-007 Injectable Solution
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All subjects receive the study treatmentAll subjects receive the study treatment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of RBM-007 in Subjects With Treatment naïve Exudative Age-related Macular Degeneration (AMD)
Actual Study Start Date :
Jun 15, 2021
Actual Primary Completion Date :
Feb 8, 2022
Actual Study Completion Date :
Mar 4, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: RBM-007 Injectable Solution - 2.0 mg

Single intravitreal injection in study eye

Drug: RBM-007 Injectable Solution
Sterile solution

Outcome Measures

Primary Outcome Measures

  1. Macular edema [3 months]

    Central subfield thickness on optical coherence tomography

Secondary Outcome Measures

  1. Visual acuity [3 Months]

    Change from Baseline in Best Corrected Visual Acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  1. Best Corrected Visual Acuity (BCVA) 5 - 73 ETDRS letters (20/800-20/40 Snellen equivalent), inclusive, in study eye

  2. Presence of choroidal neovascularization secondary to AMD

  3. 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:

  1. Active ocular or periocular infections, malignancy

  2. Aphakia

  3. History of pars plana vitrectomy in the study eye

  4. History of major ophthalmic surgery in the past 3 months in the study eye, or minor surgery in the past 30 days

  5. History of significant ocular disease other than exudative AMD that may confound results

  6. Uncontrolled glaucoma (defined as intraocular pressure >21mm Hg despite treatment with ocular hypotensive medications at baseline).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Midwest Eye Institute Indianapolis Indiana United States 46290

Sponsors and Collaborators

  • Maturi, Raj K., M.D., P.C.

Investigators

  • Study Chair: Raj K. Maturi, M.D., Midwest Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maturi, Raj K., M.D., P.C.
ClinicalTrials.gov Identifier:
NCT04895293
Other Study ID Numbers:
  • RKM-011
First Posted:
May 20, 2021
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Degeneration

Study Results

No Results Posted as of Aug 25, 2022