Safety and Efficacy of 9MW0813 in Subjects With Diabetic Macular Edema

Plain-language summary

This study evaluates the safety and efficacy of the medicine 9MW0813, together with Aflibercept, in people with diabetic macular edema. It enrolled patients with type 1 or type 2 diabetes who met certain vision and retinal thickness criteria. The study was conducted in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Intervention

9MW0813, Aflibercept

Start date

2/26/2021

Estimated completion

1/25/2022

Countries

China

Related genes

Locations

• Beijing, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Main inclusion criteria：

1. Diagnosed with type 1 or type 2 diabetes with HbA1c ≤ 11.0%;
2. Use ETDRS chart BCVA ≥ 19 letters and ≤ 73 letters (approximately equivalent to Snellen chart equivalent 20/40 to 20/400);
3. Central retinal thickness (CRT) ≥ 300 μm, (using spectral domain optical coherence tomography);
4. BCVA ≥ 24 letters in the non-study eye (approximately 20/320 equivalent on the Snellen chart).

Main exclusion criteria:

1. with proliferative diabetic retinopathy (PDR), excluding inactive, fibrotic PDR;
2. Vitreous hemorrhage within 30 days before the first administration;
3. 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;
4. 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.) ;
5. There are iris neovascularization;
6. 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.);
7. The investigator believes that the cataract may affect the judgment of the examination or test results, or requires surgical treatment during the test;
8. Aphakia (excluding intraocular lens) or posterior capsule defect (except for YAG laser posterior capsulotomy after intraocular lens implantation within 30 days);
9. History of vitrectomy.