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OpenTrials
Completed

NCT Number: NCT04186702

New Concepts in Diabetic Macular Edema (DME)

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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Key information

Conditions

Diabetes Mellitus, With Complications Diabetes Complications Diabetes Mellitus Endocrine System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

INTRAVITREAL RANIBIZUMAB INJECTION

Procedure

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

Other names: focal/direct argon laser

Primary outcomes

  1. visual acuity letter score

    Time frame: one-year follow up

    The visual acuity letter score at one-year

  2. central subfield thickness (CST)

    Time frame: one-year follow up

    the mean CST observed at one-year

Secondary outcomes

  1. patient compliant-complications

    Time frame: one-year follow up

    subjective symptoms

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: DME

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 5, 2019
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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