Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
NCT ID: NCT05802329
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2024-01-13
2026-07-31
Brief Summary
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Detailed Description
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Under the escalation design, 12 subjects will be enrolled if there are no DLTs and up to 24 subjects under the condition that exactly 1 of the 3 subjects of every cohort if determined to have a DLT.
Each subject will receive a total of 2 intravitreal injections of OCU200 6 weeks apart.
The DSMB will review the sentinel subject 1 week safety data post dosing in every cohort of all 3 subjects.
Cohort 1: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 2: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 3: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 4: 3+3 participants will receive intravitreal injection of OCU200.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
3+3 participants will receive intravitreal injection of OCU200 (0.5 mg/mL concentration).
OCU200
Intravitreal Injection
Cohort 2
3+3 participants will receive intravitreal injection of OCU200 (1 mg/ML concentration).
OCU200
Intravitreal Injection
Cohort 3
3+3 participants will receive intravitreal injection of OCU200 (2 mg/mL concentration).
OCU200
Intravitreal Injection
Cohort 4
3+3 participants will receive intravitreal injection of OCU200 (5 mg/mL concentration).
OCU200
Intravitreal Injection
Interventions
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OCU200
Intravitreal Injection
Eligibility Criteria
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Inclusion Criteria
2. Decreased visual acuity attributable primarily to DME
3. Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:
1. ≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis
2. ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus
4. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart
5. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging
6. 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.
Exclusion Criteria
2. Uncontrolled hypertension
3. Uncontrolled glaucoma
4. Concurrent disease in the study eye, other than central-involved DME
5. Intravitreal or periocular steroid treatment within 3 months prior to the screening visit
6. Any ocular surgery within 3 months prior to the screening visit in the study eye
7. Uncontrolled/poorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%)
8. History of retinal detachment in the study eye or other retinal vascular disease in the study eye
9. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit
10. Presence of any inherited retinal disease or history of proliferative diabetic retinopathy
11. History of Renal disease including stage 3b or worse
18 Years
ALL
Yes
Sponsors
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Ocugen
INDUSTRY
Responsible Party
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Principal Investigators
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Huma Qamar, MD, MPH, CMI
Role: STUDY_DIRECTOR
Ocugen
Locations
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Advanced Research LLC
Deerfield Beach, Florida, United States
Erie Retina Research, LLC
Erie, Pennsylvania, United States
Retina Consultants of Texas Research Centers
Bellaire, Texas, United States
Retina Consultants of America
Southlake, Texas, United States
Gundersen Health System
La Crosse, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OCU200-101
Identifier Type: -
Identifier Source: org_study_id
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