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

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ocugen

Criteria

Inclusion Criteria:

1. Diagnosis of Type 1 or Type 2 Diabetes Mellitus 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 if male or ≥ 305 µm if female on Heidelberg Spectralis

2. ≥ 305 if male or ≥ 290 if female on Zeiss Cirrus

3. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart (approximately 20/32 to 20/320 Snellen equivalents, respectively) in the study eye.

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

5. No history of prior anti-VEGF injection for treatment of DME or history of at least 2 consecutive anti-VEGF intravitreal injection (less than 7 weeks apart) for the treatment of DME with documented incomplete resolution of central subfield thickening within 1 year prior to the screening visit. The last injection should be within 3 months prior to the screening visit.

Exclusion Criteria:

1. Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)

2. Uncontrolled hypertension (systolic pressure above 180 mmHg or diastolic pressure above 110 mmHg)

3. Uncontrolled glaucoma

4. Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results

5. Intravitreal or periocular steroid treatment within 3 months prior to the screening visit or fluocinolone acetonide implant (Iluvien®) within 36 months prior to screening visit or dexamethasone implant (Ozurdex®) within 6 months prior to the screening visit.

6. Any ocular surgery within 3 months prior to the screening visit in the study eye (e.g., cataract surgery, corneal refractive surgery)

7. Prior vitrectomy in the study eye

8. Uncontrolled/poorly controlled diabetes, as defined by Glycated hemoglobin (HbA1c) ≥ 12%

9. History of retinal detachment in the study eye

10. History of any other retinal vascular disease in the study eye including conditions that affect macular perfusion (e.g., retinal artery occlusion, retinal vein occlusion, vasculitis)

11. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit

12. Presence of any inherited retinal disease (e.g., chorioretinal dystrophies, rod/cone dystrophies)Any proliferative diabetic retinopathy