Overview
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
Description
This is a multicenter, open-label, dose ranging study with 3 cohorts in the dose-escalation portion of the study and 1 cohort in the combination therapy portion of the study. An accelerated 3+3 design with parallel and sequential dosing will be used.
A total of 9 to 22 participants will be enrolled in the dose-escalation portion of the study to receive OCU200 alone (9 to 18 participants enrolled according to the 3+3 design and up to 4 participants replaced due to parallel cohort initiation). For the combination therapy cohort, a total of 3 to 6 participants will be enrolled to receive OCU200 (MTD) + Lucentis.
A total of up to 28 participants will be included in this study.
The DSMB will continue to review all available safety data two weeks post-dosing of participants.
Cohort 2 Medium Dose (1 mg/mL): 3+3 participants will receive intravitreal injection of OCU200 medium dose concentration. Following the same algorithm as Cohort 1.
Cohort 3 High Dose (2 mg/mL): 3+3 participants will receive intravitreal injection of OCU200 high dose concentration. Following the same algorithm as Cohort 2.
Eligibility
Inclusion Criteria:
- 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 if male or ≥ 305 µm if female on Heidelberg Spectralis
- ≥ 305 if male or ≥ 290 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 for treatment of DME or history of at least 2 consecutive anti-VEGF intravitreal injection with documented incomplete resolution.
Exclusion Criteria:
- 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
- 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 proliferative diabetic retinopathy