RecruitingPhase 1NCT05802329

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

Sponsor

Ocugen

Enrollment

24 participants

Start Date

Jan 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

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.

Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)
Uncontrolled hypertension
Uncontrolled glaucoma
Concurrent disease in the study eye, other than central-involved DME
Intravitreal or periocular steroid treatment within 3 months prior to the screening visit
Any ocular surgery within 3 months prior to the screening visit in the study eye
Uncontrolled/poorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%)
History of retinal detachment in the study eye or other retinal vascular disease in the study eye
Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit
Presence of any inherited retinal disease or history of proliferative diabetic retinopathy
History of Renal disease including stage 3b or worse