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

NCT03690947 | Completed Phase 4

• 1 other identifier: Z181100001718079
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity changes

  Compare the changes of BCVA between two groups

  12 months

Secondary Outcomes (1)

• Central Macular Thickness changes

  12 months

Study Arms (2)

Combination Therapy Group

EXPERIMENTAL

Drug: Intravitreal Ranibizumab; Procedure: Micropulse Laser

Intravitreal Ranibizumab Group

ACTIVE COMPARATOR

Drug: Intravitreal Ranibizumab; Drug: Intravitreal Ranibizumab as needed

Interventions

Intravitreal Ranibizumab DRUG

All subjections received 3 initial Ranibizumab injections

Also known as: Lucentis

Combination Therapy Group; Intravitreal Ranibizumab Group

Micropulse Laser PROCEDURE

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

Also known as: Macular Laser Photocoagulation

Combination Therapy Group

Intravitreal Ranibizumab as needed DRUG

After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization

Also known as: Lucentis

Intravitreal Ranibizumab Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 36056443 DERIVED

MeSH Terms

Interventions

Ranibizumab; Health Services Needs and Demand

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Xiaobing Yu, M.D.

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 1, 2018
• Study Start: October 1, 2018
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)