Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOcugen
About this trial
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosis of Type 1 or Type 2 Diabetes Mellitus
Decreased visual acuity attributable primarily to DME
≥ 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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
OCU200
DrugIntravitreal Injection
Treatment groups
24 Participants
are divided into 4 treatment groupsGroup A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Study Drug-related adverse events (SDAE)
Counts, frequencies and percentages of SDAEs.
Time frame
24 weeks2
Treatment-emergent adverse events (TEAEs)
Counts, frequencies and percentages TEAEs.
Time frame
24 weeks3
Serious adverse events (SAEs)
Counts, frequencies and percentages of SAEs.
Time frame
24 weeksSecondary outcomes
1
Best-corrected visual acuity (BCVA)
Measured as the ETDRS letter score on the EVA tester or E-ETDRS charts.
Time frame
24 Weeks (Changes from baseline)2
Intraocular pressure (IOP)
IOP measurement by applanation or rebound tonometry.
Time frame
24 weeks(Changes from baseline)3
Color fundus photography
Color fundus photographs will be taken to evaluate retinal anatomy and grade diabetic retinopathy severity scale (DRSS).
Time frame
24 Weeks(Changes from baseline)4
Spectral Domain Optical Coherence Tomography (SD-OCT)
SD-OCT will be utilized to assess retinal thickness. OCT images and scans will be transmitted to a central reading center for independent analysis.
Time frame
24 Weeks(Changes from baseline)Other outcomes
1
Improvement of diabetic retinopathy severity scale (DRSS)
Proportion of participants with ≥ 2-step improvement of diabetic retinopathy severity scale (DRSS)
Time frame
24 weeks2
Change from baseline in BCVA letters.
Dose response as assessed by mean change from baseline in BCVA letters and mean number of injections by study visit
Time frame
24 weeks3
Reduction of CST
The proportion of participants having a ≥ 10% reduction of CST at Week 13 and Week 19
Time frame
24 Weeks Source ClinicalTrials.gov