Status:
COMPLETED
Safety and Efficacy of 9MW0813 in Subjects With Diabetic Macular Edema
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
A multicenter, randomized, double-blind, parallel-controlled phase I trial comparing the safety, pharmacokinetics and efficacy of 9MW0813 and aflibercept (EYLEA®) after a single dose in patients with ...
Detailed Description
This is a multi-center, randomized, double-blind, parallel controlled Phase I clinical trial. The primary objective is to compare the safety of a single intravitreal injection (IVT) of 9MW0813 inject...
Eligibility Criteria
Inclusion
- Main inclusion criteria：
- Diagnosed with type 1 or type 2 diabetes with HbA1c ≤ 11.0%;
- Use ETDRS chart BCVA ≥ 19 letters and ≤ 73 letters (approximately equivalent to Snellen chart equivalent 20/40 to 20/400);
- Central retinal thickness (CRT) ≥ 300 μm, (using spectral domain optical coherence tomography);
- BCVA ≥ 24 letters in the non-study eye (approximately 20/320 equivalent on the Snellen chart).
- Main exclusion criteria:
- with proliferative diabetic retinopathy (PDR), excluding inactive, fibrotic PDR;
- Vitreous hemorrhage within 30 days before the first administration;
- Structural retinal damage involving the fovea (such as retinal pigment epithelium (RPE) atrophy, retinal fibrosis, laser scarring, dense hard exudates), or the investigator believes that the study eye has other factors that may hinder vision after macular edema subsides increased retinal damage;
- Existing ophthalmic conditions other than diabetic retinopathy that cause macular edema or vision changes (such as retinal vein occlusion (RVO), choroidal neovascularization, retinal detachment, macular hole, macular retinal traction, epiretinal membrane, etc.) ;
- There are iris neovascularization;
- Uncontrolled glaucoma (defined as intraocular pressure ≥ 25mmHg after anti-glaucoma drug treatment) or glaucoma-causing cup/optic disc ratio of the study eye \>0.8 or previous glaucoma filtering surgery (such as trabeculae); excision, sclerectomy, etc.);
- The investigator believes that the cataract may affect the judgment of the examination or test results, or requires surgical treatment during the test;
- Aphakia (excluding intraocular lens) or posterior capsule defect (except for YAG laser posterior capsulotomy after intraocular lens implantation within 30 days);
- History of vitrectomy.
Exclusion
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05324592
Start Date
February 26 2021
End Date
January 25 2022
Last Update
April 12 2022
Active Locations (1)
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1
Beijing tongren hospital affliated to capital medical university
Beijing, Beijing Municipality, China, 100000