proliferative diabetic retinopathy
Conditions
Interventions
Sponsors
EENT Hospital, Fudan University, Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form and agree to be followed up according to the schedule of the trial; 2) Aged=18, male or female; 3) Patients with PDR secondary to type 2 diabetes without CI-DME; 4) BCVA=20 letters (Snellen 20/400, decimal vision 0.05) Note: The target eye is determined by the investigator from a medical point of view if both eyes of the patient meet the inclusion criteria. In principle, the eye with poor eyesight or thicker central retina should be selected as the target eye.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria will not be eligible for the study. ? Target eye 5) Proliferative vitreoretinopathy (PVR); 6) Has macular epiretinal membranes or vitreous tractions which are considered to influence the central visual acuity by the investigator; 7) Has other diseases which are considered to influence the macular functional recovery by the investigator, e.g., foveal atrophy, subfoveal hemorrhage, macular hard exudates or dense submacular hard exudates; 8) Traction retinal detachment (TRD) and others with a history of any type of retinal detachment; 9) Severe refractive media opacity, vitreous hemorrhage, and retinal hemorrhage that affect fundus evaluation and treatment; 10) Has non-DR ocular diseases which are considered to possibly cause macular edema, declined visual acuity or retinal neovascularization during the study period by the investigator, e.g., wet AMD, diabetic retinopathy, uveitis/other intraocular inflammatory diseases, neovascular glaucoma and cystoid macular edema; 11) Crystal opacity that affects PRP completers in the opinion of the investigator; 12) Has received the following ophthalmic operations: sclera buckling, verteporfin-photodynamic therapy (PDT), vitrectomy, radial optic neurotomy/optic nerve sheathotomy, glaucoma filtration, parafoveal laser photocoagulation, pan-retinal photocoagulation, and macular translocation, etc.; 13) Has received YAG laser treatment or any other ophthalmic treatments (including cataract surgery, macular grid laser photocoagulation, local retinal photocoagulation, and keratoplasty, etc.) within three months before screening; 14) Has aphakic eye (excluding pseudophakic) or posterior lens capsule (except YAG laser posterior capsulotomy after intraocular lens implantation); 15) Has active periocular or ocular inflammation (e.g., blepharitis, infective conjunctivitis, keratitis, scleritis, uveitis, and endophthalmitis); 16) Has previous or existing uncontrollable glaucoma (defined as IOP remaining at =30mmHg after anti-glaucoma treatment),or has a cup-to-disc ratio of the eye of interest of above 0.8 due to severe glaucoma; 17) Have received ocular anti-VEGF therapy within the past 3 months; 18) Have received ocular hormone therapy within the past 6 months. ?Patients with any of the following systemic diseases 19) Has a history of anaphylaxis and allergy to fluorescein sodium, and of allergy to protein products for diagnosis or treatment, and is allergic to no less than two drugs and/or non-drug factors, or suffers from allergic diseases now; 20) Has a history of stroke, has a history of myocardial and/or cerebral infarction(s) and of transient cerebral ischemia within 6 months before screening, and has active and disseminated intravascular coagulation and distinct bleeding tendency; 21) Has diagnosed as systemic immune disease (e.g., ankylosing spondylitis, systemic lupus erythematosus, and Behcet's disease, rheumatoid arthritis, and scleroderma); 22) Has any uncontrollable clinical problem (e.g., AIDS, active hepatitis, severe mental, neurological, cardiovascular and respiratory diseases, and malignancies); 23) Hyperpietics with poor blood pressure control (defined as SBP remaining at =160mmHg or DBP remaining =100 mmHg after antihypertensives therapy); 24) Has a surgical history within one month before screening, and/or has unhealed wounds, ulcers and fractures at present; 25) Has systemically used corticosteroids (orally,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total NV (NVE and NVD) area; | — |
Secondary
| Measure | Time frame |
|---|---|
| the completion rate of PRP;BCVA;CST; | — |
Countries
china
Contacts
Public Contactxu gezhi
Outcome results
None listed