Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema
ConditionDiabetic Macular Edema (DME)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBio-Thera Solutions
About this trial
A multicenter, randomized, double-blind, parallel-group, active-controlled non-inferiority trial. A total of 406 subjects with diabetic macular edema (DME) were planned for enrollment. After screening, eligible subjects were randomized in a 1:1 ratio to the treatment group or the control group. The treatment group received BAT5906 injection, while the control group received Lucentis®. During the trial, ophthalmic examinations and safety assessments were conducted according to the protocol for efficacy and safety evaluation. Blood samples were collected for immunogenicity assessment. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in the study eye from baseline to week 52 (measured using the ETDRS chart).
Eligibility criteria
Qualifiers
Voluntarily signed informed consent form, willing and able to comply with outpatient visits and study procedures as scheduled by the trial.
Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years (including boundary values).
Diabetic macular edema (DME) with OCT findings demonstrating involvement of the macular center (fovea or paracentral fovea) in the study eye. (fovea or parafovea);
Central retinal thickness (CRT) of the study eye >300 μm (or >320 μm for Heidelberg OCT) as assessed by central image review during screening;
Disqualifiers
Presence of structural damage in the central macula of the study eye that may prevent improvement in best-corrected visual acuity after resolution of macular edema, including retinal pigment epithelial cell atrophy, subretinal fibrosis or scarring, significant macular ischemia (as indicated by marked disruption of the arcade pattern on fluorescein angiography), or histochemical sclerosing exudates. 2. Vitreomacular traction or epimacular membrane deemed by the investigator to significantly impair visual improvement;
Presence of any condition in the study eye other than diabetic macular edema that may confound fundus evaluation or visual acuity testing (e.g., retinal vascular occlusion, retinal detachment, optic nerve ischemia, vitreomacular traction, macular hole, pre-retinal fibrosis involving the macula, choroidal neovascularization, age-related macular degeneration);
Aphakia in the study eye or presence of an intraocular lens with posterior capsule opacification (exemption granted for posterior capsule opacification resulting from YAG capsulotomy, provided a 1-month washout period is met);
The study eye has uncontrolled glaucoma (intraocular pressure >25 mmHg despite antiglaucoma medication); or a history of glaucoma filtration surgery; or plans for antiglaucoma surgery during the study period;
Trial design
Treatments tested in this trial
- BAT5906 injection
- Lucentis
Treatment groups
406 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov