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Trial record 25 of 143 for:    MPL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Aflibercept Injection Other: micropulsed yellow laser Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aflibercept With Adjuvant Micro-Pulsed Yellow Laser Versus Aflibercept Monotherapy in Treatment of Diabetic Macular Edema.
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : June 21, 2017
Actual Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Group A
received aflibercept injections alone
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

Experimental: Group B
received 3 aflibercept injections followed by micropulsed laser
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.




Primary Outcome Measures :
  1. the number of intravitreal injections [ Time Frame: 18th month follow-up. ]
    the total number of intravitreal aflibercept injections were recorded

  2. Central macular thickness [ Time Frame: 18 month ]
    in um


Secondary Outcome Measures :
  1. best corrected visual acuity measured in ETDRS. [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866746


Locations
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Kuwait
AlHadi hospital
Ḩawallī, AlJabryia, Kuwait, 123
Sponsors and Collaborators
Al Hadi Hospital
Investigators
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Principal Investigator: Abeer M Khattab, MD Al Hadi Hospital

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Responsible Party: Abeer MohamedSadeck Khattab, associate professor of ophthalmology, Al Hadi Hospital
ClinicalTrials.gov Identifier: NCT03866746     History of Changes
Other Study ID Numbers: AlHadi Hospital
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Abeer MohamedSadeck Khattab, Al Hadi Hospital:
Aflibercept
Anti-VEGFs
micropulsed diode laser
subthreshold
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases