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

Phase 4

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Intravitreal Ranibizumab; Drug: Intravitreal Ranibizumab as needed; Procedure: Micropulse Laser

• Registration Number: NCT03690947
• Lead Sponsor: Beijing Hospital

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.

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study Start: 2018-10-01
• Study First Posted: 2018-10-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-25
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Therapy Group	Intravitreal Ranibizumab	-
Intravitreal Ranibizumab Group	Intravitreal Ranibizumab as needed	-
Combination Therapy Group	Micropulse Laser	-
Intravitreal Ranibizumab Group	Intravitreal Ranibizumab	-

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity changes	12 months	Compare the changes of BCVA between two groups

Secondary Outcome Measures

Name	Time	Method
Central Macular Thickness changes	12 months	Compare the changes of CMT between two groups

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China