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NCT04527107 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

A Phase 2 study of Diabetes Mellitus and Diabetic Macular Edema, sponsored by Oxurion.

Completed
Registry status
Phase 2
Development phase
135
Enrollment target
20
Study locations

NCT04527107 is a Phase 2 study of Diabetes Mellitus and Diabetic Macular Edema that has completed, run by Oxurion. The registered enrollment target is 135 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT04527107, a Phase 2 study of Diabetes Mellitus and Diabetic Macular Edema, has completed, sponsored by Oxurion.

COMPLETED
Registry status
Phase 2
Development phase
135 participants
Enrollment target
20
Study locations

Study Summary

Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

Conditions Studied

Diabetes Mellitus Diabetic Macular Edema Diabetic Retinopathy

Interventions

  • DRUG THR-149 dose level 1
  • DRUG THR-149 dose level 2
  • DRUG THR-149 dose level 3
  • DRUG THR-149 0.13mg
  • DRUG THR-149 0.13mg + aflibercept 2mg

Study Locations (20)

California

  • Retina-Vitreous Associates Medical Group - Beverly Hills
  • Salehi Retina Institute Inc. - Huntington Beach
  • Northern California Retina Vitreous Associates Medical Group, Inc. - Mountain View
  • California Retina Consultants - Oxnard
  • Retina Consultants San Diego - Poway
  • Retinal Consultants Medical Group - Sacramento

Florida

  • Blue Ocean Clinical Research - Clearwater
  • Fort Lauderdale Eye Institute - Plantation
  • MedEye Associates - South Miami
  • Center for Retina and Macular Disease - Winter Haven

Arizona

  • Retinal Research Institute, LLC - Phoenix
  • Retina Associates - Tucson

Georgia

  • Southeast Retina Center - Augusta
  • Marietta Eye Clinic - Marietta

Colorado

  • Retina Consultants of Southern Colorado, P.C. - Colorado Springs

Illinois

  • University Retina and Macula Associates, PC - Oak Forest

Maryland

  • Cumberland Valley Retina Consultants - Hagerstown

Massachusetts

  • Joslin Diabetes Center - Boston

Trial Details

FieldValue
Enrollment Target 135 participants
Start Date 2020-07-31
Est. Completion 2023-11-22
Phase Phase 2

Sponsor

Oxurion

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04527107

The ClinicalTrials.gov registry entry for NCT04527107 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (93% lower). The listed sponsor is Oxurion, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 5 interventions - of which THR-149 dose level 1 is the first listed.

NCT04527107 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT04527107 about?

NCT04527107 is a clinical study titled "A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema". Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibe...

What is the current status of trial NCT04527107?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2020-07-31. Estimated completion is 2023-11-22.

What conditions does trial NCT04527107 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Diabetic Macular Edema, Diabetic Retinopathy.

What interventions are being tested in trial NCT04527107?

The interventions under investigation include: THR-149 dose level 1 (DRUG), THR-149 dose level 2 (DRUG), THR-149 dose level 3 (DRUG), THR-149 0.13mg (DRUG), THR-149 0.13mg + aflibercept 2mg (DRUG).

Who is sponsoring clinical trial NCT04527107?

This trial is sponsored by Oxurion, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04527107 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.