- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04186702
New Concepts in Diabetic Macular Edema (DME) (DME)
New Concepts in Diabetic Macular Edema (DME) Ranibizumab and Focal/Direct Laser for Chronic Diabetic Macular Edema With Vision Impairment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Settings and Design: Randomized clinical study
Subjects and Methods:
investigators randomly assigned 150 adults (the average age was 59.32 years ±2.79) with chronic diabetic macular edema involving the macular center for repeated ranibizumab injections (group A-75) or focal/direct argon laser after repeated ranibizumab injections (group B-75). The outcomes were the changes in visual acuity letter score and the central subfield thickness (CST) from baseline to one year. visual-acuity Letter score, and CST were analyzed with independent t-test and Mann Whitney-test. General linear model with multivariate analysis was used for visual acuity letter score, and CST in both groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- focal maculopathy
- diffuse macular edema
- diffuse macular edema with ischemic changes
Exclusion Criteria:
- ischemic maculopathy that was associated with grades of non-proliferative changes, or capillary drop out zones presented in the periphery of the macula
- patients with history of stroke or transient ischemic attack
- hypersensitivity to ranibizumab or any component of the ranibizumab formulation
- uncontrolled glaucoma in either eye (intraocular pressure [IOP] >24 mmHg with medication)
- evidence of vitreomacular traction (in either eye)
- active proliferative diabetic retinopathy (study eye)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: visual acuity letter score
visual acuity letter score is used to compare between the two groups after interventional procedures
|
interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)
Other Names:
|
Active Comparator: macular thickness(CST)
macular thickness(CST)is used to compare between the two groups after interventional procedures
|
interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual acuity letter score
Time Frame: one-year follow up
|
The visual acuity letter score at one-year
|
one-year follow up
|
central subfield thickness (CST)
Time Frame: one-year follow up
|
the mean CST observed at one-year
|
one-year follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient compliant-complications
Time Frame: one-year follow up
|
subjective symptoms
|
one-year follow up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FWA000017585 FMASU22/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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