Center Involved Diabetic Macular Edema, Diabetic Macular Edema
Conditions
Keywords
anti-VEGF, Transferrin, Tumstatin, DME
Brief summary
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
Detailed description
This is a multicenter, open-label, dose ranging study with 4 cohorts in the dose-escalation portion of the study. An accelerated 3+3 design with parallel and sequential dosing will be used. 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.
Interventions
DRUGOCU200
Intravitreal Injection
Sponsors
Ocugen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3+3 design with parallel and sequential dosing.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 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
1. Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Drug-related adverse events (SDAE) | 24 weeks | Counts, frequencies and percentages of SDAEs. |
| Treatment-emergent adverse events (TEAEs) | 24 weeks | Counts, frequencies and percentages TEAEs. |
| Serious adverse events (SAEs) | 24 weeks | Counts, frequencies and percentages of SAEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected visual acuity (BCVA) | 24 Weeks (Changes from baseline) | Measured as the ETDRS letter score on the EVA tester or E-ETDRS charts. |
| Intraocular pressure (IOP) | 24 weeks(Changes from baseline) | IOP measurement by applanation or rebound tonometry. |
| Color fundus photography | 24 Weeks(Changes from baseline) | Color fundus photographs will be taken to evaluate retinal anatomy and grade diabetic retinopathy severity scale (DRSS). |
| Spectral Domain Optical Coherence Tomography (SD-OCT) | 24 Weeks(Changes from baseline) | SD-OCT will be utilized to assess retinal thickness. OCT images and scans will be transmitted to a central reading center for independent analysis. |
| Spectral Domain Optical Coherence Tomography Angiography (SD-OCTA) | 24 weeks (Changes from baseline) | SD-OCTA will be utilized to assess retinal vasculature and images will be transmitted to a central reader for independent analysis. |
| Wide-field Fluorescein Angiography (wf-FA) | 24 weeks (Changes from baseline) | wf-FA will be conducted at screening and EOS visits to assess central and peripheral vasculature. |
Countries
United States
Contacts
CONTACTRoshan A George, MD, MPH
CONTACTOscar Cuzzani, MD, PhD
STUDY_DIRECTORJennifer Henrick, RN, MS
Ocugen
STUDY_CHAIRMohamed Genead, MD
Ocugen
Outcome results
None listed