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

NCT04332133 | Completed DMC

• 1 other identifier: Diabetic Macular Edema(DME)
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Diabetic Macular Edema

Keywords

DME, mfERG, SML, ranibizumab,IV.injection

Outcome Measures

Primary Outcomes (3)

• central subfield thickness in micrometer

  OCT for the macular area with measuring CST in micron

  6 months

• p1 amplitude of mfERG

  p1 amplitude of multifocal ERG measured in nv/deg2

  6mnths

• BCVA

  BCVA is measured in decimal of Snellen visual acuity

  6 months

Study Arms (3)

group 1

ACTIVE COMPARATOR

group 1 of DME which treated by SML

Procedure: laser interference,INTRAVITREAL INJECTION

group 2

ACTIVE COMPARATOR

Group 2 of DME which treated by intravitreal injection of Ranibizumab

Procedure: laser interference,INTRAVITREAL INJECTION

group 3

NO INTERVENTION

control group of diabetic patients received no treatment

Interventions

laser interference,INTRAVITREAL INJECTION PROCEDURE

sub threshold micro pulse laser for DME for group 1 and intravitreal injection of Ranibizumab for group 2

group 1; group 2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Minia University: lead

Related Publications (5)

• Klein R, Knudtson MD, Lee KE, Gangnon R, Klein BE. The Wisconsin Epidemiologic Study of Diabetic Retinopathy XXIII: the twenty-five-year incidence of macular edema in persons with type 1 diabetes. Ophthalmology. 2009 Mar;116(3):497-503. doi: 10.1016/j.ophtha.2008.10.016. Epub 2009 Jan 22.

  PMID: 19167079 BACKGROUND

• Lung JC, Swann PG, Wong DS, Chan HH. Global flash multifocal electroretinogram: early detection of local functional changes and its correlations with optical coherence tomography and visual field tests in diabetic eyes. Doc Ophthalmol. 2012 Oct;125(2):123-35. doi: 10.1007/s10633-012-9343-0. Epub 2012 Jul 25.

  PMID: 22828871 BACKGROUND

• Yamamoto S, Yamamoto T, Hayashi M, Takeuchi S. Morphological and functional analyses of diabetic macular edema by optical coherence tomography and multifocal electroretinograms. Graefes Arch Clin Exp Ophthalmol. 2001 Feb;239(2):96-101. doi: 10.1007/s004170000238.

  PMID: 11372551 BACKGROUND

• Fortune B, Schneck ME, Adams AJ. Multifocal electroretinogram delays reveal local retinal dysfunction in early diabetic retinopathy. Invest Ophthalmol Vis Sci. 1999 Oct;40(11):2638-51.

  PMID: 10509661 BACKGROUND

• Abdelrahman A, Massoud W, Elshafei AMK, Genidy M, Abdallah RMA. Anatomical and functional outcomes of subthreshold micropulse laser versus intravitreal ranibizumab injection in treatment of diabetic macular edema. Int J Retina Vitreous. 2020 Dec 3;6(1):63. doi: 10.1186/s40942-020-00265-6.

  PMID: 33292788 DERIVED

MeSH Terms

Interventions

Intravitreal Injections

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Raafat Abdallah, A.professor

  ophthalmology department,faculty of medicine, minia university

  PRINCIPAL INVESTIGATOR

• Mahmoud Genidy, professor

  ophthalmology department,faculty of medicine, minia university

  STUDY DIRECTOR

• Wagiha Massoud, professor

  ophthalmology department,faculty of medicine, minia university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of ophthalmology

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Study Start: December 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after publication has been completed
• Access Criteria: personal communication through email or through this site if possible