Clinical trial NCT03690947: Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of DME
Official title: Randomized, Double-blinded, Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2018-10-01
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Best Corrected Visual Acuity changes
timeFrame: 12 months
Secondary outcomes:
measure: Central Macular Thickness changes
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Xiaobing Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.