Cytokine and Visual Outcome Variations in Eyes Receiving Ranibizumab
Status:
Recruiting
Trial end date:
2024-02-28
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
St. Michael's Hospital, Toronto Unity Health Toronto