diabetic retinopathy
Conditions
Interventions
single arm:Intravitreal injection of thunderzumab
Sponsors
School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-65 years old (including boundary limit), regardless of gender; 2) Visual acuity was 20/25 to 20/100 (46-80 ETDRS letters); 3) Diagnosed as severe NPDR (more than one of 4-2-1); Or mild PDR by FFA, retinal neovascularization in at least 1 quadrant of the retina; 4) Mild focal diabetic macular edema with CRT <= 400um on OCT. 5)The DRSS score of the modified ETDRS seven fields color fundus photography was between 47 and 61. 6) The subjects of fellow eye: high-risk proliferative diabetic retinopathy, vitreous hemorrhage and tractional retinal detachment, or poor visual acuity after vitrectomy priority entry; 7) Agreed to be treated according to the plan, signed the informed consent, and will complete the follow-up observation as required. Note: if both eyes met inclusion criteria and agree to treatment, study eye was determined by the researcher.
Exclusion criteria
Exclusion criteria: 1) Objective eye had received any anti-VEGF therapy or had a history of systemic anti-VEGF therapy. 2) Objective eye had received panretinal photocoagulation or focal retinal photocoagulation in the peripherals; 3) Objective eye has obvious subfoveal fibrosis, scar or atrophy; 4) Objective eye had received corneal transplantation, vitrectomy, macular transposition and glaucoma surgery. 5) Patients who had undergone cataract surgery within 3 months before the study eye screening; 6)Objective eye has serious refractive interstitial opacity; 7)Objective eye or the fellow eye have active eye infections (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis) or recurrence infection; 8) Ever or now suffer from uncontrolled glaucoma (after treatment for glaucoma intraocular pressure > 25 mmHg), or objective eye caused severe glaucoma concave/optic disc ratio > 0.8, received a green light or target eye filtration surgery; 9) Objective eye without crystal (not including artificial crystal eyes) or posterior capsular rupture (after intraocular lens implantation of YAG laser capsulotomy after except); 10) History of allergic reaction for FFA/ICGA examination or allergic for protein products used in therapeutic or diagnostic,as well as allergic for more than two drugs and/or non-drugs, or present allergic diseases; 11) Diabetic patients with uncontrolled blood glucose (glycosylated hemoglobin >= 10%); 12)Hypertension with unsatisfactory blood pressure control (defined as blood pressure >= 160/95 mmHg after antihypertensive drug treatment); 13) History of myocardial infarction and/or cerebral infarction within 6 months prior to the screening; Pass support and rely on anticoagulants such as warfarin, aspirin; 14) Long-term use of aspirin, clopidogrel, warfarin and other anticoagulants and can not stop; 15) Systemic disease are receiving or requiring treatment (except hypertension or diabetes); 16) The researchers think patients need to be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DASS score regresses 2 levels in ETDRS seven fundus color photos; | — |
Secondary
| Measure | Time frame |
|---|---|
| FA evaluated the rate of regression of microhemangioma, IRMA, or retinal neovascularization in the target eye;The proportion of target eye lesions reactivating in ETDRS seven fundus color photos;The proportion of target eye lesions reactivating inFA;The proportion requiring repeated injection and the proportion requiring retinal photocoagulation;Changes in vision from baseline; | — |
Countries
China
Contacts
Public ContactZuhua Sun
School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University
Outcome results
None listed