A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME
ConditionDiabetic Macular Edema (DME)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEnnovaBio
About this trial
This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. The study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.
Eligibility criteria
Qualifiers
Provide written informed consent;
Aware of the entire study process and requirements, understands the importance of medication compliance and completing all assessments on time throughout the study, and agrees to strictly follow the protocol and study procedures, including restrictions on drug combination during the study;
Diagnosis of type 1 or type 2 diabetes mellitus and HbA1c≤10.0% with regular use hypoglycemic drugs and stable glycemic control 1 month before screening (at the discretion of the investigator);
The decrease of BCVA is mainly caused byDiabetic Macular Edema in the study eye;
Disqualifiers
Study eye with any eye disease or medical history other than DME that causes or may cause irreversible vision loss;
Study eye had glaucoma filtration surgery in the past or may have the surgery during the study;
Study eye had previously undergone vitreoretinal surgery;
Study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to baseline;
Trial design
Treatments tested in this trial
- ENN0403, low dose
- ENN0403, high dose
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov