Mean Visual Acuity Changes Following Five Injections of Aflibercept

NCT02645266 | Active Not Recruiting

• 1 other identifier: BHC-RD-SOP-038
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic Macular Edema is a serious ocular consequence of poorly controlled diabetes. Even though significant research has been done to clarify the pathogenesis of DME, a clear causal pathway of the complication is of yet undetermined. However, there is some consensus among researchers that a cascade of inflammatory markers plays an important role in the disease process. The study hopes to better delineate the role these inflammatory markers play by investigating whether basal levels predict response or lack thereof to Aflibercept.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• To determine change in BCVA from baseline to month 5 of aflibercept treatment

  To determine mean visual acuity letters gain following 4 injections Aflibercept compared to baseline.

  5 months

Study Arms (1)

Aflibercept Injection [Eylea] group

EXPERIMENTAL

Intervention: Subjects will be receiving a (2mg/ml) dose of VEGF-Trap, injected intravitreally at the start of every month, for the 4 months duration of the trial.

Drug: Aflibercept Injection [Eylea]

Interventions

Aflibercept Injection [Eylea] DRUG

Subjects will be administered 2.0mg Aflibercept intraocular injection each month for 5 consecutive months. After the 5th month, the serum cytokine levels in blood work will be assessed as well as patients's visual acuity, and eye pressures. Upon completion of the trial, patients will resume receiving the usual standard of care.

Also known as: Eylea treatment

Aflibercept Injection [Eylea] group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of DME by a retina specialist
• Age: 18 or older
• VA between 25 and 75 letters at baseline
• Treatment naïve

You may not qualify if:

• Unwilling to sign consent form
• Previous anti-VEGF intravitreal treatment in affected eye
• Actively taking systemic steroids
• Ocular inflammatory disease or autoimmune disease
• Previous laser treatment for DME within last 3 months .
• Any ocular surgery within the last 3 months.
• Previous retina surgery( PPV, ERM surgery etc)
• Medically uncontrolled glaucoma
• Any other retinal condition( CRAO, CRVO, wAMD, geographic atrophy)
• Individuals with disabilities that prevent accurate vision testing
• Proliferative diabetic retinopathy

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8G 5E4, Canada

Location

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 1, 2016
• Study Start: May 1, 2018
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CA (1)