Diabetic retinopathy (DR)
Conditions
Interventions
8 mg aflibercept group:Aflibercept 8 mg every 16 weeks (HDq16)
2 mg aflibercept group:Aflibercept 2 mg every 8 weeks (2q8)
Sponsors
Bejing Tongren Hospital, Capital Medical Uniersity
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Men or women >=18 years of age; 2. Chinese participants with type 1 or type 2 diabetes mellitus and diabetic macular edema (DME) with central involvement defined as CST >=300 µm (or >=320 µm on Heidelberg Spectralis) in the study eye as determined by the reading center at the screening visit and confirmed by the site at baseline visit; 3. BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye at the screening and baseline visits with decreased vision determined to be primarily the result of DME; 4. Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for participation in clinical studies and fulfil the conditions set in Section 10.4.2; 5. Capable of giving signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol; 6. Willing and able to comply with clinic visits and study-related procedures;
Exclusion criteria
Exclusion criteria: 1. Evidence of macular edema due to any cause other than diabetes mellitus in either eye; 2. Active proliferative diabetic retinopathy in the study eye; 3. IOP >=25 mmHg in the study eye; 4. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye within 4 weeks (28 days) of the screening visit or at the baseline visit; 5. Any intraocular inflammation/infection in either eye within 12 weeks (84 days) of the screening visit or at the baseline visit; 6. History of idiopathic or autoimmune uveitis in the study eye; 7. Vitreomacular traction or epiretinal membrane in the study eye evident on biomicroscopy or OCT that is considered by the investigator to significantly affect central vision or preclude improvement in vision; 8. Preretinal fibrosis involving the macula in the study eye; 9. Any history of macular hole of stage 2 and above in the study eye; 10. Myopia of a spherical equivalent of >= 8 diopters (based on current refraction or medical history prior to any refractive or cataract surgery) in the study eye; 11. Current anterior segment (iris or angle) neovascularization, vitreous hemorrhage, or tractional retinal detachment visible at the screening or baseline visits in the study eye; 12. History of corneal transplant or corneal dystrophy in study eye; 13. Aphakia, or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium-aluminum-garnet [YAG] posterior capsulotomy performed more than 28 days before the screening visit), in the study eye; 14. Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the participant beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety; 15. The study eye is the participant’s only functional eye; 16. Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia, or organized hard exudates; 17. Ocular conditions with poorer prognosis in the fellow eye; 18. Inability to obtain photographs, FA, or SD-OCT in the study eye (e.g., due to media opacity, allergy to fluorescein dye, or lack of venous access); 19. Systemic infection at the time of screening or baseline. Or systemic treatment for suspected or active systemic infection at screening or baseline visit; 20. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug or that might affect interpretation of the results of the study or render the participant at high risk for treatment complications; 21. Uncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) > 12%; 22. Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg). 23. History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) of the screening visit; 24. Renal failure, dialysis, or history of renal transplant; 25. Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in the study eye within 12 weeks (84 days) of the screening visit; 26. IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in BCVA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Pharmacokinetics (PK);Immunogenicity; | — |
Countries
China
Contacts
Public ContactWenbin Wei
Bejing Tongren Hospital, Capital Medical Uniersity
Outcome results
None listed