- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04895293
RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration (TEMPURA)
Evaluation of RBM-007 in Subjects With Treatment naïve Exudative Age-related Macular Degeneration (AMD)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46290
- MidWest Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RBM-007 Injectable Solution - 2.0 mg
Single intravitreal injection in study eye
|
Sterile solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Macular Edema
Time Frame: 3 months
|
Central subfield thickness on optical coherence tomography
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Acuity
Time Frame: 3 Months
|
Change from Baseline in Best Corrected Visual Acuity
|
3 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Raj K. Maturi, M.D., MidWest Eye Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RKM-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Age Related Macular Degeneration
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheWithdrawnNeovascular Age-Related Macular DegenerationDenmark, Argentina, Hong Kong, Thailand, Portugal, Greece, Spain
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationSpain, Italy, Germany, Canada, Ireland
-
Novartis PharmaceuticalsTerminatedNeovascular Age-Related Macular Degeneration
-
Regeneron PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
-
Hoffmann-La RocheRecruitingNeovascular Age Related Macular Degeneration | nAMDChina
-
Innostellar Biotherapeutics Co.,LtdRecruitingNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheRecruitingNeovascular Age-Related Macular DegenerationBelgium, United States, United Kingdom, Italy, Argentina, Spain, Israel, Australia, Austria, Brazil, Germany, Switzerland, Taiwan, France
-
Hoffmann-La RocheCompletedNeovascular Age-Related Macular DegenerationUnited States
-
First Affiliated Hospital of Chongqing Medical...Enrolling by invitationExudative Age-Related Macular DegenerationChina
Clinical Trials on RBM-007 Injectable Solution
-
Ribomic USA IncCompletedAge-related Macular DegenerationUnited States
-
Ribomic USA IncCompletedExudative Age-related Macular DegenerationUnited States
-
Ribomic USA IncCompletedExudative Age-related Macular DegenerationUnited States
-
Alcon ResearchTerminatedOcular Hypertension | Open-angle Glaucoma
-
Pamukkale UniversityCompletedPrimary DysmenorrheaTurkey
-
University of EdinburghNHS LothianWithdrawnBronchiectasis | Immunoglobulin Subclass DeficiencyUnited Kingdom
-
Connecticut Children's Medical CenterRecruitingPost-operative Pain | MacromastiaUnited States
-
RegeneRx Biopharmaceuticals, Inc.WithdrawnST Elevation Myocardial Infarction | Acute Myocardial Infarction | STEMI
-
Wolfson Medical CenterSanofi; Assaf-Harofeh Medical CenterUnknown
-
Dove Medical Press LtdHainan Medical CollegeCompleted