A Phase 4 interventional study of Intravitreal aflibercept in Age Related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion, sponsored by Unity Health Toronto. Status unknown at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by Unity Health Toronto · Phase 4, Interventional, and Treatment
Objective: To determine the association between baseline aqueous cytokine levels and treatment intervals for patients under a variable dosing regimen with intravitreal aflibercept in patients with neovascular age-related macular degeneration (nAMD), macular edema secondary to retinal vein occlusion (RVO) and diabetic macular edema (DME).
Methods: A prospective, single-centre study will be performed containing 3 sub-studies according to each study population: nAMD, macular edema secondary to RVO and DME. Inclusion criteria are: patients followed at St. Michael's Hospital with the diagnosis of nAMD, macular edema secondary to RVO or DME. Patients will be excluded if visual acuity is worse than counting fingers, with macular pathologies causing any structural changes to the retina, have received anti-VEGF injections or photocoagulation therapy 6 months prior to study, intraocular surgery 3 months prior to study, any history of vitreoretinal surgery or ocular inflammation in the study eye, use of systemic or topical anti-inflammatory or steroids, patients on dialysis for renal failure, allergy to the study drug or fluorescein, \<18 years old, women who are pregnant. All patients will be treated with aflibercept intravitreal injections on a variable dosing regimen: Patients with DME will be examined monthly and receive mandatory injection for the first three months (baseline, weeks 4 and 8). Afterwards, they will continue to be seen monthly and the need for new injections will be decided upon the clinical findings at each visit. An anterior chamber (AC) tap will be done if an injection is required at the visit. Patients with nAMD and RVO will be examined monthly and receive mandatory injection for the first three months. From weeks 12 until 72 (month 18), the visits will be scheduled at increasing 2-weeks intervals based on the stability of the ocular condition and response to treatment. At each visit, an injection and AC tap will be performed. The maximum interval in between injections is 12 weeks. If the disease becomes unstable, the interval in between injections is shortened and, once it stabilizes, the treatment frequency is extended again. In all patients, baseline aqueous humour specimens will be obtained prior to the first aflibercept intravitreal injection and follow-up samples will be taken immediately prior to subsequent injections based on the treatment regimens for cytokine analysis in the end of the follow-up.
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Exclusion Criteria:
Previous intravitreal drug injections in either eye within 6 months prior to study enrollment
Patients presenting to St. Michael's Hospital retina clinic with neovascular AMD, macular edema secondary to retinal vein occlusion and diabetic macular edema treated with intravitreal aflibercept in a variable dosing regimen.
Drug: Intravitreal aflibercept
Patients will receive intravitreal aflibercept on a variable dosing regimen and have aqueous humor sample obtained for cytokine analysis at every visit when an intravitreal injection is done.
Also known as: Eylea
Association between cytokine levels and optimal treatment interval
Optimal interval between injections based on aqueous cytokine levels
Time frame: 18 months
Individualized aqueous cytokine curves relationship with treatment response
Aqueous cytokine curves for each patient based on the relationship between cytokine levels and treatment response
Time frame: 18 months
Cytokine threshold level with visual and anatomic outcomes
Cytokine threshold level below which visual and anatomic outcomes are greatest
Time frame: 18 months
Snellen BCVA change
To assess Snellen Best Corrected Visual Acuity (BCVA) change at months 1 and 2, and at the visits scheduled for each injection throughout an 18 months period.
Time frame: months 1 and 2, and at the visits scheduled for each injection throughout an 18 months period.
ETDRS visual acuity change
Visual acuity (ETDRS) change at month 2 (at the third injection), at the visits closest to injection of months 6, 12 and 18.
Time frame: month 2, at the visits closest to injection of months 6, 12 and 18.
Optical coherence tomography change
Anatomic OCT change (Macular Volume, Central Macular Thickness) at months 1 and 2, and at the visits scheduled for each injection throughout an 18 months period.
Time frame: months 1 and 2, and at the visits scheduled for each injection throughout an 18 months period.
Average number of injections needed
Average number of injections needed in a variable dosing regimen protocol over an 18 months period.
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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