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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690947
• Other study ID #: Z181100001718079
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2022
• Source: Beijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• Intravitreal Ranibizumab
All subjections received 3 initial Ranibizumab injections

Procedure:
• Micropulse Laser
After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists

Drug:
• Intravitreal Ranibizumab as needed
After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity changes	Compare the changes of BCVA between two groups	12 months
Secondary	Central Macular Thickness changes	Compare the changes of CMT between two groups	12 months