New Concepts in Diabetic Macular Edema (DME)

Diabetes Mellitus, With Complications Clinical Trial

— DME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186702
• Other study ID #: FWA000017585 FMASU22/2017
• Status: Completed
• Phase: N/A
• Start date: September 10, 2014
• Est. completion date: September 9, 2017

Study information

• Verified date: December 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 9, 2017
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, With Complications
• Macular Edema

Intervention

Procedure:
• INTRAVITREAL RANIBIZUMAB INJECTION
interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity letter score	The visual acuity letter score at one-year	one-year follow up
Primary	central subfield thickness (CST)	the mean CST observed at one-year	one-year follow up
Secondary	patient compliant-complications	subjective symptoms	one-year follow up