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OpenTrials
Completed

NCT Number: NCT04895293

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

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.

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Key information

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

RBM-007 Injectable Solution

Drug

Sterile solution

Primary outcomes

  1. Macular Edema

    Time frame: 3 months

    Central subfield thickness on optical coherence tomography

Secondary outcomes

  1. Visual Acuity

    Time frame: 3 Months

    Change from Baseline in Best Corrected Visual Acuity

Sponsors and collaborators

Lead sponsor

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

Indiv

Registry information

Official study title

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

Acronym: TEMPURA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 20, 2021
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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