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

Study Overview
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Brief Summary
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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.

Detailed Description
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To investigate the efficacy of intravitreal ranibizumab injections compared to combination with Micropulse Laser in Chinese patients with visual impairment in DME. The result of the study will be used to support new therapy in DME patients in China.

Official Title
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Randomized, Double-blinded, Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of Diabetic Macular Edema

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Intravitreal Ranibizumab
* Procedure: Micropulse Laser
* Drug: Intravitreal Ranibizumab as needed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination Therapy Group<br> | Drug: Intravitreal Ranibizumab<br>* All subjections received 3 initial Ranibizumab injections<br>* Other names: Lucentis;Procedure: Micropulse Laser<br>* After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists<br>* Other names: Macular Laser Photocoagulation;|
| Active Comparator: Intravitreal Ranibizumab Group<br> | Drug: Intravitreal Ranibizumab<br>* All subjections received 3 initial Ranibizumab injections<br>* Other names: Lucentis;Drug: Intravitreal Ranibizumab as needed<br>* After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity changes | Compare the changes of BCVA between two groups | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Macular Thickness changes | Compare the changes of CMT between two groups | 12 months |