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Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema (MPL)

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ClinicalTrials.gov Identifier: NCT03866746
Recruitment Status : Completed
First Posted : March 7, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abeer MohamedSadeck Khattab, Al Hadi Hospital

Tracking Information
First Submitted Date  ICMJE March 1, 2019
First Posted Date  ICMJE March 7, 2019
Last Update Posted Date July 4, 2019
Actual Study Start Date  ICMJE May 8, 2017
Actual Primary Completion Date June 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
  • the number of intravitreal injections [ Time Frame: 18th month follow-up. ]
    the total number of intravitreal aflibercept injections were recorded
  • Central macular thickness [ Time Frame: 18 month ]
    in um
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03866746 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
best corrected visual acuity measured in ETDRS. [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema
Official Title  ICMJE Aflibercept With Adjuvant Micro-Pulsed Yellow Laser Versus Aflibercept Monotherapy in Treatment of Diabetic Macular Edema.
Brief Summary prospective study evaluating the impact of subthreshold micropulsed laser on the number of Aflibercept injections when used as an adjuvant therapy in eyes with diabetic macular edema.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • Drug: Aflibercept Injection
    Group A;Under complete aseptic conditions; intravitreal aflibercept injections with dose of 2 mg/0.05 mL per injection was given for the patients. Patients were scheduled to receive 3 loading injections at monthly interval. At the 3rd month; further treatment was planned pro re nata (PRN) according to the response. Injections were discontinued when the CMT reached 250 µm or less. If there was no change in the CMT after two consecutive injections; patients shifted to other line of treatment. Reinjection was continued for the other eyes with re-evaluation of the response every month.In group B Patients received the initial 3 monthly loading doses of IVI of aflibercept followed by MPL therapy (within one week after the 3rd injection). Patients were scheduled for follow-up monthly. Injection followed by MPL was then repeated according to the response as in group A.
    Other Name: Micropulsed yellow laser
  • Other: micropulsed yellow laser
    Micropulse yellow IQ 577nm laser (Iridex Corporation, Mountain View, CA, USA) was employed. The Area Centralis lens (laser spot size magnification 0.94) was utilized with 400 mw power, 200μm spot size and 200 ms pulse duration with 5% duty cycle after micropulse mode activation. Laser was applied on clinically visible thickened macula with different number of confluent non- spacing shots in 7x7 grids. Care was taken to begin treatment outside the foveal avascular zone and not to treat the fovea when there was no visible reaction. If there was any visible reaction; treatment was stopped and the power was reduced until there was no visible reaction.
Study Arms  ICMJE
  • Active Comparator: Group A
    received aflibercept injections alone
    Intervention: Drug: Aflibercept Injection
  • Experimental: Group B
    received 3 aflibercept injections followed by micropulsed laser
    Interventions:
    • Drug: Aflibercept Injection
    • Other: micropulsed yellow laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2019)
51
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 28, 2018
Actual Primary Completion Date June 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • older than 18 years old
  • diagnosed with DME with central macular thickness (CMT) more than 250 µm measured by OCT
  • best corrected visual acuity (BCVA) between 20/400 and 20/40.

Exclusion Criteria:

  • patients with intra-ocular surgery as cataract surgery within 6 months
  • prior intravitreal injection of any drug within the preceding 6 months
  • panretinal photocoagulation (PRP) within the former 4 months.
  • Patients with previous macular laser
  • patients with vitreo-macular traction (VMT) syndrome
  • severe glaucoma
  • other retinal vascular diseases
  • conditions that impede the OCT interpretation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kuwait
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03866746
Other Study ID Numbers  ICMJE AlHadi Hospital
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Abeer MohamedSadeck Khattab, Al Hadi Hospital
Study Sponsor  ICMJE Al Hadi Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abeer M Khattab, MD Al Hadi Hospital
PRS Account Al Hadi Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP