Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser

NCT03143192 | Completed Phase 2

• 1 other identifier: 19228
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this pilot study is to investigate the safety and efficacy of micropulse (MP) macular laser in combination with intravitreal aflibercept for the treatment of centre-involved diabetic macular edema.

Conditions

Diabetic Macular Edema

Keywords

DME, Micropulse Laser, Anti-VEGF

Outcome Measures

Primary Outcomes (1)

• Number of injections for each group

  Number of intravitreal injections for each group

  48 weeks

Secondary Outcomes (11)

• Changes in visual acuity

  24 weeks

• Changes in visual acuity

  48 weeks

• Changes in OCT Central Macular Thickness and Volume

  24 weeks

• Changes in OCT Central Macular Thickness and Volume

  48 weeks

• Number of injections half way

  24 weeks

Study Arms (2)

Aflibercept with Micropulse Laser

EXPERIMENTAL

Aflibercept 2mg (0.05mL) injected intravitreally every 4 weeks or as needed Micropulse Laser at initial visit and reassessed every 12 weeks.

Combination Product: Micropulse Laser

Aflibercept with Sham Laser

SHAM COMPARATOR

Aflibercept 2mg (0.05mL) injected intravitreally every 4 weeks or as needed Sham Laser at initial visit and reassessed every 12 weeks.

Device: Sham Laser

Interventions

Micropulse Laser COMBINATION_PRODUCT

Aflibercept injection with Micropulse laser.

Aflibercept with Micropulse Laser

Sham Laser DEVICE

Aflibercept injection with Sham Laser

Aflibercept with Sham Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type I or Type II Diabetes Mellitus
• Presence of centre-involved Diabetic Macular Edema (DME) with the Central Macular Thickness (CMT) of ≥ 310µm on the spectral-domain Optical Coherence Tomography (OCT)
• Best corrected Visual Acuity (BCVA) between, and including, 20/30 and 20/400 in the study eye.
• Patient's willingness and ability to attend the study visits

You may not qualify if:

• Any other potential causes of macular edema such as active uveitis, epiretinal membrane, post-operative CME, and vitromacular traction
• Any history of major intraocular surgery (such as cataract surgery or vitrectomy) in the study eye within prior six months, or anticipated need for intraocular surgery within the next six months from the enrollment
• Any major ocular pathology limiting potential vision such as large macular scars, vitreous hemorrhage, corneal opacities, visually significant cataracts, advanced glaucoma, or other types of optic neuropathy
• Any history of Panretinal Photocoagulation (PRP) in the study eye or anticipated need for PRP within the next 6 months from enrollment
• Any history of DME treatment (focal laser, anti-VEGF, or intraocular/periocular steroids) in the study eye in the past 4 months prior to the enrollment
• Significant renal disease requiring dialysis
• Significant heart disease, stroke or transient ischemic attack requiring hospitalization in the past 4 months prior to the study
• Presence of active ocular or periocular infection
• Presence of active intraocular inflammation
• Known hypersensitivity to aflibercept or to any ingredient in the formulation or to any component of the container

Sponsors & Collaborators

• Keyvan Koushan: lead

Study Sites (2)

Mississauga Retina Institute

Mississauga, Ontario, L4X 2Z9, Canada

Location

Toronto Retina Institute

Toronto, Ontario, M3C 0G9, Canada

Location

Related Publications (1)

• Koushan K, Eshtiaghi A, Fung P, Berger AR, Chow DR. Treatment of Diabetic Macular Edema with Aflibercept and Micropulse Laser (DAM Study). Clin Ophthalmol. 2022 Apr 8;16:1109-1115. doi: 10.2147/OPTH.S360869. eCollection 2022.

  PMID: 35422607 DERIVED

Study Officials

• Keyvan Koushan, MD, FRCSC

  Toronto Retina Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and technicians (measuring ocular coherence tomography, fluorescein auto fluorescence and visual acuity) will be masked. The investigator and study coordinator will be unmasked to direct the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a parallel study comparing the results of patients who receive aflibercept and micropulse laser versus those who only receive aflibercept. The second group will receive sham laser to prevent placebo effects.

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 8, 2017
• Study Start: March 8, 2017
• Primary Completion: May 9, 2019
• Study Completion: May 9, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)