Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of DME
NCT ID: NCT03690947
Last Updated: 2022-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
72 participants
INTERVENTIONAL
2018-10-01
2021-09-30
Brief Summary
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Detailed Description
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The result of the study will be used to support new therapy in DME patients in China.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Combination Therapy Group
Intravitreal Ranibizumab
All subjections received 3 initial Ranibizumab injections
Micropulse Laser
After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists
Intravitreal Ranibizumab Group
Intravitreal Ranibizumab
All subjections received 3 initial Ranibizumab injections
Intravitreal Ranibizumab as needed
After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization
Interventions
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Intravitreal Ranibizumab
All subjections received 3 initial Ranibizumab injections
Micropulse Laser
After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists
Intravitreal Ranibizumab as needed
After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
80 Years
ALL
No
Sponsors
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Beijing Hospital
OTHER_GOV
Responsible Party
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Yu Xiaobing
M.D.
Principal Investigators
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Xiaobing Yu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Hospital
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Countries
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References
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Mi X, Gu X, Yu X. The efficacy of micropulse laser combined with ranibizumab in diabetic macular edema treatment: study protocol for a randomized controlled trial. Trials. 2022 Sep 2;23(1):736. doi: 10.1186/s13063-022-06593-2.
Other Identifiers
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Z181100001718079
Identifier Type: -
Identifier Source: org_study_id