New Concepts in Diabetic Macular Edema (DME)

Study Overview
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Brief Summary
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Intravitreal ranibizumab injection procedure is simple and effective. In management of chronic DME there is no clear anatomical endpoint. Visual stability is the primary aim. Argon focal laser therapy can be the safe second choice. The combined therapy is successful and practical for chronic DME patients.

Detailed Description
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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.

Official Title
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New Concepts in Diabetic Macular Edema (DME) Ranibizumab and Focal/Direct Laser for Chronic Diabetic Macular Edema With Vision Impairment

Conditions
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Diabetes Mellitus, With Complications

Intervention / Treatment
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* Procedure: INTRAVITREAL RANIBIZUMAB INJECTION


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: interventional model
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: visual acuity letter score<br>visual acuity letter score is used to compare between the two groups after interventional procedures | Procedure: INTRAVITREAL RANIBIZUMAB INJECTION<br>* interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)<br>* Other names: focal/direct argon laser;|
| Active Comparator: macular thickness(CST)<br>macular thickness(CST)is used to compare between the two groups after interventional procedures | Procedure: INTRAVITREAL RANIBIZUMAB INJECTION<br>* interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)<br>* Other names: focal/direct argon laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity letter score | The visual acuity letter score at one-year | one-year follow up | 
| central subfield thickness (CST) | the mean CST observed at one-year | one-year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient compliant-complications | subjective symptoms | one-year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macula-injection- laser- ranibizumab-edema-thickness