New Concepts in Diabetic Macular Edema (DME)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-10

Study Completion Date

2017-09-09

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.

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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.

Conditions

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Diabetes Mellitus, With Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

interventional model

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

A clinical trial design strategy in which parties involved in the trial, the investigator and participants, do not know which participants have been assigned which interventions. Type of masking include: double-blind masking.

Study Groups

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visual acuity letter score

visual acuity letter score is used to compare between the two groups after interventional procedures

Group Type ACTIVE_COMPARATOR

INTRAVITREAL RANIBIZUMAB INJECTION

Intervention Type PROCEDURE

interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)

macular thickness(CST)

macular thickness(CST)is used to compare between the two groups after interventional procedures

Group Type ACTIVE_COMPARATOR

INTRAVITREAL RANIBIZUMAB INJECTION

Intervention Type PROCEDURE

interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)

Interventions

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INTRAVITREAL RANIBIZUMAB INJECTION

interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)

Intervention Type PROCEDURE

Other Intervention Names

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focal/direct argon laser

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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No