New Concepts in Diabetic Macular Edema (DME)

NCT04186702 | Completed DMC

• 1 other identifier: FWA000017585 FMASU22/2017
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Mellitus, With Complications

Keywords

macula-injection- laser- ranibizumab-edema-thickness

Outcome Measures

Primary Outcomes (2)

• visual acuity letter score

  The visual acuity letter score at one-year

  one-year follow up

• central subfield thickness (CST)

  the mean CST observed at one-year

  one-year follow up

Secondary Outcomes (1)

• patient compliant-complications

  one-year follow up

Study Arms (2)

visual acuity letter score

ACTIVE COMPARATOR

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

Procedure: INTRAVITREAL RANIBIZUMAB INJECTION

macular thickness(CST)

ACTIVE COMPARATOR

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

Procedure: INTRAVITREAL RANIBIZUMAB INJECTION

Interventions

INTRAVITREAL RANIBIZUMAB INJECTION PROCEDURE

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

Also known as: focal/direct argon laser

macular thickness(CST); visual acuity letter score

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• focal maculopathy
• diffuse macular edema
• diffuse macular edema with ischemic changes

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: interventional model

Study Record Dates

• First Submitted: November 30, 2019
• First Posted: December 5, 2019
• Study Start: September 10, 2014
• Primary Completion: October 1, 2016
• Study Completion: September 9, 2017
• Last Updated: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share