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NCT05066997 · ClinicalTrials.gov registry record · Phase 2

A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)

A Phase 2 study of Diabetic Macular Edema, sponsored by Oculis.

Active
Registry status
Phase 2
Development phase
552
Enrollment target
20
Study locations

NCT05066997 is a Phase 2 study of Diabetic Macular Edema that is active but no longer recruiting, run by Oculis. The registered enrollment target is 552 participants, below the 3,786-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT05066997, a Phase 2 study of Diabetic Macular Edema, is active but no longer recruiting, sponsored by Oculis.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
552 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS- 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).

Conditions Studied

Diabetic Macular Edema

Interventions

  • DRUG Vehicle
  • DRUG Dexamethasone ophthalmic suspension (OCS-01)

Study Locations (20)

California

  • Retina-Vitreous Associates Medical Group - Beverly Hills
  • The Retina Partners - Encino
  • Retinal Consultants Medical Group - Modesto
  • California Eye Specialists Medical Group - Pasadena
  • California Eye Specialists Medical Group - Redlands
  • Retina Consultants of Southern California - Redlands
  • California Retina Consultants - Santa Maria

Florida

  • Rand Eye Institute - Deerfield Beach
  • Florida Retina Institute - Jacksonville
  • MedEye Associates - Miami
  • Florida Retina Institute - Orlando
  • Retina Care Specialists - Palm Beach Gardens
  • East Florida Eye Institute - Stuart

Arizona

  • Arizona Retina and Vitreous Consultants - Phoenix
  • Phoenix Retina Associates - Phoenix

Illinois

  • Retina Associates - Elmhurst
  • University Retina - Lemont

Arkansas

  • Retina Partners of Northwest Arkansas - Springdale

Connecticut

  • Retina Group Of New England - Waterford

Georgia

  • Southeast Retina Center - Augusta

Trial Details

FieldValue
Enrollment Target 552 participants
Start Date 2021-10-19
Est. Completion 2026-04
Phase Phase 2

Sponsor

Oculis

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05066997

The ClinicalTrials.gov registry entry for NCT05066997 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 552 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,786-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (85% lower). The listed sponsor is Oculis, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.

NCT05066997 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT05066997 about?

NCT05066997 is a clinical study titled "A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)". The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS- 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).

What is the current status of trial NCT05066997?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 552 participants. The study started on 2021-10-19. Estimated completion is 2026-04.

What conditions does trial NCT05066997 study?

This clinical trial studies the following conditions: Diabetic Macular Edema.

What interventions are being tested in trial NCT05066997?

The interventions under investigation include: Vehicle (DRUG), Dexamethasone ophthalmic suspension (OCS-01) (DRUG).

Who is sponsoring clinical trial NCT05066997?

This trial is sponsored by Oculis, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05066997 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.