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NCT05802329 · ClinicalTrials.gov registry record · Phase 1

Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)

A Phase 1 study of Diabetic Macular Edema and Center Involved Diabetic Macular Edema, sponsored by Ocugen.

Recruiting
Registry status
Phase 1
Development phase
24
Enrollment target
5
Study locations

NCT05802329: Recruiting Phase 1 study of Diabetic Macular Edema and Center Involved Diabetic Macular Edema, sponsored by Ocugen.

NCT05802329 is a Phase 1 study of Diabetic Macular Edema and Center Involved Diabetic Macular Edema that is actively recruiting participants, run by Ocugen. The registered enrollment target is 24 participants, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05802329, a Phase 1 study of Diabetic Macular Edema and Center Involved Diabetic Macular Edema, is actively recruiting participants, sponsored by Ocugen.

RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
5
Study locations

Study Summary

A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema

Primary Outcome

Counts, frequencies and percentages of SDAEs.

Interventions

  • DRUG OCU200

Study Locations (5)

Texas

  • Retina Consultants of Texas Research Centers - Bellaire
  • Retina Consultants of America - Southlake

Florida

  • Advanced Research LLC - Deerfield Beach

Pennsylvania

  • Erie Retina Research, LLC - Erie

Wisconsin

  • Gundersen Health System - La Crosse

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2024-01-13
Est. Completion 2026-07-31
Phase Phase 1
Ocugen

8 total trials

What NCT05802329 shows while recruiting

NCT05802329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which OCU200 is the first listed.

NCT05802329 lists 5 locations in 4 states (Texas, Florida, Pennsylvania).

Frequently Asked Questions

What is clinical trial NCT05802329 about?

NCT05802329 is a clinical study titled "Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)". A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema

What is the current status of trial NCT05802329?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-01-13. Estimated completion is 2026-07-31.

What conditions does trial NCT05802329 study?

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

What interventions are being tested in trial NCT05802329?

The interventions under investigation include: OCU200 (DRUG).

Who is sponsoring clinical trial NCT05802329?

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

Where is trial NCT05802329 being conducted?

This trial has 5 study locations across Florida, Pennsylvania, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetic Macular Edema

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05802329's enrollment target sits among peer trials

24 51st of 63 higher than 13 of 63 other Diabetic Macular Edema trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetic Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05802329, the US trial registry maintained by the National Library of Medicine. NCT05802329 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.