Diabetic Macular Edema
Conditions
Interventions
Combination Therapy Group:Combination of Intravitreal Ranibizumab Injection With Macular Laser Photocoagulation
Intravitreal Ranibizumab Group:Intravitreal Ranibizumab Injection
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent form must be signed before any tests or procedures; 2. Male or female of 30 to 80 years of age (inclusive) at the first screening visit; 3. Diagnosis of type 2 diabetes, with fasting blood glucose=10mmol/L, HbA1C=10.0%; 4. Diabetic medication must be stable for at least 3 months before first screening visit and remain stable during study; 5. Diagnosis of non-proliferative diabetic retinopathy with diabetic macular edema resulting in visual acuity reduction; 6. Study eyes BCVA between 24 to 78 ETDRS letters at screening and baseline of the study; 7. Macular edema of the study eye and central retinal thickness =300 µm determined by SD-OCT; 8. Study eye had not had grid pattern photocoagulation, intraocular surgery, intravitreal corticosteroid injections and intravitreal anti-VEGF injections for at least 3 months before baseline; 9. Non-study eyes BCVA = 24 ETDRS letters at screening and baseline of the study; 10. Non-study eye had not had intravitreal anti-VEGF injections for at least 3 months before baseline; 11. If both eyes qualify, then investigators will choose an eye with worse BCVA as study eye. Only study eye will receive intravitreal ranibizumab and/or Micropulse Diode Laser treatment.
Exclusion criteria
Exclusion criteria: 1. Failure to follow study or follow-up procedures; 2. Pregnant or breast-feeding woman and woman without adequate method of contraception; 3. History of stroke or myocardial infarction within 3 months before screening; 4. Renal failure or creatinine > 2.0 mg/dl; 5. Uncontrolled systemic diseases or systemic treatment that may affect results of the study; 6. Active ocular or intraocular infections of either eye; 7. Neovascularization of the iris or neovascular glaucoma of either eye; 8. A history of uveitis or vitreous macular traction in either eye; 9. Glaucoma or IOP=24 mmHg of study eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Best Corrected Visual Acuity; | — |
Countries
China
Contacts
Public ContactXiaobing Yu
Beijing Hospital
Outcome results
None listed