A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Diagnosis of Type 1 or Type 2 Diabetes Mellitus

• Decreased visual acuity attributable primarily to DME

• Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:

‣ ≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis

⁃ ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus

• BCVA ≤ 78 and ≥ 24 letters on ETDRS chart

• Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging

• No history of prior anti-VEGF injection or history of at least 2 consecutive intravitreal anti-VEGF injection (less than 7 weeks apart) with incomplete resolution of CST within 1 year.

∙ Note: The last anti-VEGF injection must be administered at least six weeks (45 days) prior to the study treatment (Day 1) in the study eye.

Locations
United States
Florida
Advanced Research LLC
RECRUITING
Deerfield Beach
Pennsylvania
Erie Retina Research, LLC
RECRUITING
Erie
Texas
Retina Consultants of Texas Research Centers
RECRUITING
Bellaire
Retina Consultants of America
RECRUITING
Southlake
Wisconsin
Gundersen Health System
RECRUITING
La Crosse
Contact Information
Primary
Roshan A George, MD, MPH
roshan.george@ocugen.com
845-664-1505
Backup
Oscar Cuzzani, MD, PhD
Oscar.Cuzzani@ocugen.com
Time Frame
Start Date: 2024-01-13
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 24
Treatments
Experimental: Cohort 1
3+3 participants will receive intravitreal injection of OCU200 (0.5 mg/mL concentration).
Experimental: Cohort 2
3+3 participants will receive intravitreal injection of OCU200 (1 mg/ML concentration).
Experimental: Cohort 3
3+3 participants will receive intravitreal injection of OCU200 (2 mg/mL concentration).
Experimental: Cohort 4
3+3 participants will receive intravitreal injection of OCU200 (5 mg/mL concentration).
Sponsors
Leads: Ocugen

This content was sourced from clinicaltrials.gov

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