Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03056079
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2017-02-01
Brief Title:
Cytokine and Visual Outcome Variations in Eyes Receiving Aflibercept
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
Cytokine and Visual Outcome Variations in Eyes Receiving a Variable Dosing Aflibercept Treatment The COVARIANT Study
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVARIANT
Brief Summary:
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 Michaels 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
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 Michaels 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None