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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
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring DME, mfERG, SML, ranibizumab,IV.injection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 30, 2020
    Last Updated
    April 1, 2020
    Sponsor
    Minia University
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    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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