Diabetic Macular Edema
Conditions
Brief 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.
Detailed description
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.
Interventions
All subjections received 3 initial Ranibizumab injections
PROCEDUREMicropulse Laser
After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists
DRUGIntravitreal Ranibizumab as needed
After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization
Sponsors
Beijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity changes | 12 months | Compare the changes of BCVA between two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Macular Thickness changes | 12 months | Compare the changes of CMT between two groups |
Countries
China
Outcome results
None listed