Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of DME

• Status: Unknown status
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate if combination of intravitreal ranibizumab with micropulse laser shows non inferiority compared to intravitreal ranibizumab only in diabetic macular edema.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Hospital
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Informed consent form must be signed before any tests or procedures are done

• Male or female of 30 to 80 years of age (inclusive) at the first screening visit

• Diagnosis of type 2 diabetes, with fasting blood glucose≤10mmol/L, HbA1C≤10.0%

• Diabetic medication must be stable for at least 3 months before first screening visit and remain stable during study

• Diagnosis of non-proliferative diabetic retinopathy with diabetic macular edema resulting in visual acuity reduction

• Study eye's BCVA between 24 to 78 ETDRS letters at screening and baseline of the study

• Macular edema of the study eye and central retinal thickness ≥300 µm determined by SD-OCT

• 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

• Non-study eye's BCVA ≥ 24 ETDRS letters at screening and baseline of the study

• Non-study eye had not had intravitreal anti-VEGF injections for at least 3 months before baseline

• 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 Laser treatment

Exclusion Criteria:

• Failure to follow study or follow-up procedures

• Pregnant or breast-feeding woman and woman without adequate method of contraception

• History of stroke or myocardial infarction within 3 months before screening

• Renal failure or creatinine > 2.0 mg/dl

• Uncontrolled systemic diseases or systemic treatment that may affect results of the study

• Active ocular or intraocular infections of either eye

• Neovascularization of the iris or neovascular glaucoma of either eye

• A history of uveitis or vitreous macular traction in study eye

• Glaucoma or IOP≥24 mmHg of study eye