New Concepts in Diabetic Macular Edema (DME) (DME)

December 4, 2019 updated by: khaled hamdi elbaklish, Ain Shams University

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: 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
Procedure: INTRAVITREAL RANIBIZUMAB INJECTION
interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)
Other Names:
  • focal/direct argon laser
Active Comparator: macular thickness(CST)
macular thickness(CST)is used to compare between the two groups after interventional procedures
Procedure: INTRAVITREAL RANIBIZUMAB INJECTION
interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)
Other Names:
  • focal/direct argon laser

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

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

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)

September 10, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

September 9, 2017

Study Registration Dates

First Submitted

November 30, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 4, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWA000017585 FMASU22/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data processed and saved in eye center in the college

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.

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