Outcomes of Subthreshold Laser Versus Intravitreal Injection of Ranibizumab in Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laser interference,INTRAVITREAL INJECTION
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring DME, mfERG, SML, ranibizumab,IV.injection
Eligibility Criteria
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 .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
group 1
group 2
group 3
Arm Description
group 1 of DME which treated by SML
Group 2 of DME which treated by intravitreal injection of Ranibizumab
control group of diabetic patients received no treatment
Outcomes
Primary Outcome Measures
central subfield thickness in micrometer
OCT for the macular area with measuring CST in micron
p1 amplitude of mfERG
p1 amplitude of multifocal ERG measured in nv/deg2
BCVA
BCVA is measured in decimal of Snellen visual acuity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04332133
Brief Title
Outcomes of Subthreshold Laser Versus Intravitreal Injection of Ranibizumab in Diabetic Macular Edema
Official Title
Anatomical and Functional Outcomes of Subthreshold Micropulse Laser Versus Intravitreal Ranibizumab Injection in Treatment of Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
DME, mfERG, SML, ranibizumab,IV.injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
group 1 of DME which treated by SML
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
Group 2 of DME which treated by intravitreal injection of Ranibizumab
Arm Title
group 3
Arm Type
No Intervention
Arm Description
control group of diabetic patients received no treatment
Intervention Type
Procedure
Intervention Name(s)
laser interference,INTRAVITREAL INJECTION
Intervention Description
sub threshold micro pulse laser for DME for group 1 and intravitreal injection of Ranibizumab for group 2
Primary Outcome Measure Information:
Title
central subfield thickness in micrometer
Description
OCT for the macular area with measuring CST in micron
Time Frame
6 months
Title
p1 amplitude of mfERG
Description
p1 amplitude of multifocal ERG measured in nv/deg2
Time Frame
6mnths
Title
BCVA
Description
BCVA is measured in decimal of Snellen visual acuity
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raafat Abdallah, A.professor
Organizational Affiliation
ophthalmology department,faculty of medicine, minia university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahmoud Genidy, professor
Organizational Affiliation
ophthalmology department,faculty of medicine, minia university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wagiha Massoud, professor
Organizational Affiliation
ophthalmology department,faculty of medicine, minia university
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
19167079
Citation
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.
Results Reference
background
PubMed Identifier
22828871
Citation
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.
Results Reference
background
PubMed Identifier
11372551
Citation
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.
Results Reference
background
PubMed Identifier
10509661
Citation
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.
Results Reference
background
PubMed Identifier
33292788
Citation
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.
Results Reference
derived
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Outcomes of Subthreshold Laser Versus Intravitreal Injection of Ranibizumab in Diabetic Macular Edema
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