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
Qualifiers
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
Treatments tested in this trial
- OCU200
Treatment groups
24 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov