Outcomes of Subthreshold Laser Versus Intravitreal Injection of Ranibizumab in Diabetic Macular Edema

April 1, 2020 updated by: Raafat Mohyeldeen Abdelrahman Abdallah, Minia University

Anatomical and Functional Outcomes of Subthreshold Micropulse Laser Versus Intravitreal Ranibizumab Injection in Treatment of Diabetic Macular Edema

The aim of this study is To compare the anatomical and functional results of intravitreal( IV) injection of ranibizumab with sub threshold micropulse laser ( SML) in treatment of Diabetic macular edema (DME) both anatomically by spectral domain optical coherence tomography (SD OCT) and functionally by best-corrected visual acuity (BCVA) and multifocal electroretinogram (mfERG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic macular edema (DME) causes significant visual loss in diabetic patients. About 20% and 40% of patients with Type 1 and Type 2 diabetes mellitus (DM), respectively, develop DME. One-third of diabetic patients who have had DM for more than twenty years will develop DME . Early impairment in the function of the middle and inner layers of the retina has been reported in diabetic patients before appearance of vascular complications . A good independent guide of macular function in patients with DME is multifocal electroretinogram (mfERG) readings from the macular area, which strongly associate with morphologic alterations in the macula. Some investigators suggested that temporal characteristic (implicit time) of mfERG waves are more important than amplitudes for evaluation of retinal function in diabetic patients. They concluded that patients with DM show temporal changes indicating delayed neural transmission due to local impairment of blood glucose metabolism. In contrast, others emphasize the importance of both parameters (implicit time and amplitude) in identifying retinal affection in DM.

Intravitreal (IV) injections of anti-vascular endothelial growth factor (VEGF) agents provided good visual outcomes in treatment of DME. However, IV anti-VEGF injections are expensive, need to be repeated many times and have the potential risk of causing endophthalmitis . Subthreshold micropulse laser (SML) treatment of DME has the same effect as conventional laser treatment, nonetheless, there is less damage to adjacent tissues of the burn area in the retinal pigment epithelium (RPE). SML allows laser emission to be divided into bursts of short cyclic pulses that remain for microseconds permitting substantial cooling amid these short pulses .

Study Type

Interventional

Enrollment (Actual)

80

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:

  • DME with BCVA<0.5 decimal Snellen acuity.
  • Controlled blood glucose (HbA1c) <6.5%.

Exclusion Criteria:

  • History of previous intraocular surgery,
  • History of previous laser treatment,
  • History of previous IV injection,
  • Macular disease or ischemia,
  • Proliferative diabetic retinopathy,
  • Vitreoretinal traction,
  • Interruption of external limiting membrane (ELM) or ellipsoid zone (EZ).
  • Dense media opacity,
  • Optic disc pathology
  • History of strokes or ischaemic heart diseases.
  • patients with (CST) > 400 µm on OCT .

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1
group 1 of DME which treated by SML
Procedure: laser interference,INTRAVITREAL INJECTION
sub threshold micro pulse laser for DME for group 1 and intravitreal injection of Ranibizumab for group 2
Active Comparator: group 2
Group 2 of DME which treated by intravitreal injection of Ranibizumab
Procedure: laser interference,INTRAVITREAL INJECTION
sub threshold micro pulse laser for DME for group 1 and intravitreal injection of Ranibizumab for group 2
No Intervention: group 3
control group of diabetic patients received no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central subfield thickness in micrometer
Time Frame: 6 months
OCT for the macular area with measuring CST in micron
6 months
p1 amplitude of mfERG
Time Frame: 6mnths
p1 amplitude of multifocal ERG measured in nv/deg2
6mnths
BCVA
Time Frame: 6 months
BCVA is measured in decimal of Snellen visual acuity
6 months

Collaborators and Investigators

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

Sponsor

Minia University

Investigators

  • Principal Investigator: Raafat Abdallah, A.professor, ophthalmology department,faculty of medicine, minia university
  • Study Director: Mahmoud Genidy, professor, ophthalmology department,faculty of medicine, minia university
  • Study Chair: Wagiha Massoud, professor, ophthalmology department,faculty of medicine, minia university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diabetic Macular Edema(DME)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results can be shred after the end of the work.

IPD Sharing Time Frame

after publication has been completed

IPD Sharing Access Criteria

personal communication through email or through this site if possible

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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