- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03056092
Cytokine and Visual Outcome Variations in Eyes Receiving Ranibizumab (COVERT)
Cytokine and Visual Outcome Variations in Eyes Receiving a Variable Dosing Ranibizumab Treatment: The COVERT Study
Objective: To determine the association between baseline aqueous cytokine levels and treatment intervals for patients under a variable dosing regimen with intravitreal ranibizumab 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 ranibizumab 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 ranibizumab 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Toronto, Canada
- Recruiting
- Sunnybrook Health Sciences Centre
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Ontario
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Toronto, Ontario, Canada, M5C 2T2
- Recruiting
- Department of Ophthalmology, St Michael's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of active choroidal neovascularization secondary to AMD in the study eye
- Diagnosis of macular edema secondary to RVO: central macular thickness >310μm due to intraretinal or subretinal edema in the study eye as measured on OCT
- Diagnosis of DME with central macular thickness >310μm in the study eye as measured on OCT in patients with diabetes mellitus types 1 or 2
Exclusion Criteria:
- Previous intravitreal drug injections in either eye within 6 months prior to study enrollment
- Visual acuity worse than counting fingers
- Patients with other macular pathologies causing structural changes to the retina
- Patients with large submacular hemorrhages or extensive fibrosis occupying the majority (>50%) of the lesion
- Intraocular surgery in the study eye 3 months prior to study enrollment
- Previous vitreoretinal surgery in the study eye
- Previous photodynamic or macular photocoagulation therapy within the past 6 months in the study eye for patients with AMD
- Previous photocoagulation therapy within 6 months in the study eye or anticipated need for during the course of the study for patients with RVO
- Presence of active proliferative diabetic retinopathy or patients who have had pan-retinal photocoagulation within 6 months or patients where the need to pan-retinal photocoagulation is anticipated during the course of the study for patients with DME
- History of intraocular inflammation in the study eye
- Patients on systemic or topical anti-inflammatory or steroids medications
- Patients receiving dialysis for renal failure
- Known allergy to the study drug or fluorescein
- Patients who are pregnant
- Unwilling or unable to follow or comply with all study related procedures or to sign consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: AMD/RVO/DME
Patients presenting to St. Michael's Hospital retina clinic with neovascular age related macular degeneration, macular edema secondary to RVO and diabetic macular edema treated with intravitreal ranibizumab in a variable dosing regimen.
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Patients will be treated with intravitreal ranibizumab and have their aqueous humor obtained for cytokine analysis at every visit that an intravitreal injection is done
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between aqueous cytokine levels and optimal treatment interval
Time Frame: 18 months
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Optimal treatment intervals based on aqueous cytokine levels
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average number of injections needed
Time Frame: 18 months
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Average number of injections needed in a variable dosing regimen protocol over an 18 months period.
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18 months
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Individualized relationships between aqueous cytokines and treatment response
Time Frame: 18 months
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Aqueous cytokine curves for each patient over based on the relationship between cytokine levels and treatment response
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18 months
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Relationship between cytokine threshold level and visual/anatomic outcomes
Time Frame: 18 months
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Cytokine threshold level below which visual and anatomic outcomes are greatest
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18 months
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Snellen visual acuity change
Time Frame: months 1, 2 and at every visit scheduled for each injection throughout 18 months period
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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
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months 1, 2 and at every visit scheduled for each injection throughout 18 months period
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ETDRS visual acuity change
Time Frame: month 2, visits closest to injection of months 6, 12 and 18
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Visual acuity (ETDRS) change at month 2 (at the third injection), at the visits closest to injection of months 6, 12 and 18.
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month 2, visits closest to injection of months 6, 12 and 18
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Optical coherence tomography (OCT) change
Time Frame: months 1 and 2, and at the visits scheduled for each injection throughout an 18 months period.
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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.
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months 1 and 2, and at the visits scheduled for each injection throughout an 18 months period.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Macular Degeneration
- Macular Edema
- Retinal Vein Occlusion
- Edema
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- COVERT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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