Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema (MPL)
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 4
Locations
Kuwait
Study Type
Interventional
Intervention
Aflibercept Injection
micropulsed yellow laser
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Aflibercept, Anti-VEGFs, micropulsed diode laser, subthreshold
Eligibility Criteria
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
Sites / Locations
- AlHadi hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A
Group B
Arm Description
received aflibercept injections alone
received 3 aflibercept injections followed by micropulsed laser
Outcomes
Primary Outcome Measures
the number of intravitreal injections
the total number of intravitreal aflibercept injections were recorded
Central macular thickness
in um
Secondary Outcome Measures
best corrected visual acuity measured in ETDRS.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03866746
Brief Title
Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema
Acronym
MPL
Official Title
Aflibercept With Adjuvant Micro-Pulsed Yellow Laser Versus Aflibercept Monotherapy in Treatment of Diabetic Macular Edema.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
June 21, 2017 (Actual)
Study Completion Date
December 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al Hadi Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Aflibercept, Anti-VEGFs, micropulsed diode laser, subthreshold
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
received aflibercept injections alone
Arm Title
Group B
Arm Type
Experimental
Arm Description
received 3 aflibercept injections followed by micropulsed laser
Intervention Type
Drug
Intervention Name(s)
Aflibercept Injection
Other Intervention Name(s)
Micropulsed yellow laser
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
micropulsed yellow laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
the number of intravitreal injections
Description
the total number of intravitreal aflibercept injections were recorded
Time Frame
18th month follow-up.
Title
Central macular thickness
Description
in um
Time Frame
18 month
Secondary Outcome Measure Information:
Title
best corrected visual acuity measured in ETDRS.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abeer M Khattab, MD
Organizational Affiliation
Al Hadi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AlHadi hospital
City
Ḩawallī
State/Province
AlJabryia
ZIP/Postal Code
123
Country
Kuwait
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema
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