Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of DME
December 25, 2022 updated by: Yu Xiaobing, Beijing Hospital
Randomized, Double-blinded, Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of Diabetic Macular Edema
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Beijing Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Combination Therapy Group
|
All subjections received 3 initial Ranibizumab injections
Other Names:
After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists
Other Names:
|
|
Active Comparator: Intravitreal Ranibizumab Group
|
All subjections received 3 initial Ranibizumab injections
Other Names:
After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Best Corrected Visual Acuity changes
Time Frame: 12 months
|
Compare the changes of BCVA between two groups
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Central Macular Thickness changes
Time Frame: 12 months
|
Compare the changes of CMT between two groups
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xiaobing Yu, M.D., Beijing Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
September 28, 2018
First Submitted That Met QC Criteria
September 28, 2018
First Posted (Actual)
October 1, 2018
Study Record Updates
Last Update Posted (Actual)
December 28, 2022
Last Update Submitted That Met QC Criteria
December 25, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z181100001718079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Email yuxiaobing@sina.com
for individual participant data
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.