Clinical trial NCT05324592: Safety and Efficacy of 9MW0813 in Subjects With Diabetic Macular Edema
Official title: 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 Diabetic Macular Edema (DME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Macular Edema
Keywords: aflibercept
biosimilarity
safety
pharmacokinetics
pharmacodynamics
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 diabetic macular edema (DME).

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 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients.

The secondary objectives are to comparing the pharmacokinetic profile, immunogenicity and efficacy of a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: baseline to week 6
Secondary outcomes:
measure: Peak Plasma Concentration（Cmax） of 9MW0813 and aflibercept
timeFrame: baseline to week 6
measure: Area under the plasma concentration versus time curve (AUC) of 9MW0813 and aflibercept
timeFrame: baseline to week 6
measure: Immunogenicity of IVT injection of 9MW0813 and aflibercept
timeFrame: baseline to week 6
measure: Change from Baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: baseline to week 6
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing tongren hospital affliated to capital medical university
state: Beijing
Study officials:
References: