New Concepts in Diabetic Macular Edema (DME)

A

Ain Shams University

Status

Completed

Conditions

Diabetes Mellitus, With Complications

Treatments

Procedure: INTRAVITREAL RANIBIZUMAB INJECTION

Study type

Interventional

Funder types

Other

Identifiers

NCT04186702
FWA000017585 FMASU22/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 2 patient groups

visual acuity letter score
Active Comparator group
Description:
visual acuity letter score is used to compare between the two groups after interventional procedures
Treatment:
Procedure: INTRAVITREAL RANIBIZUMAB INJECTION
macular thickness(CST)
Active Comparator group
Description:
macular thickness(CST)is used to compare between the two groups after interventional procedures
Treatment:
Procedure: INTRAVITREAL RANIBIZUMAB INJECTION

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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