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

Beijing Hospital

Status and phase

Completed

Phase 4

Conditions

Diabetic Macular Edema

Treatments

Procedure: Micropulse Laser

Drug: Intravitreal Ranibizumab

Drug: Intravitreal Ranibizumab as needed

Study type

Interventional

Funder types

Other

Identifiers

NCT03690947

Z181100001718079

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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