NCT03056092: COVERT

Cytokine and Visual Outcome Variations in Eyes Receiving Ranibizumab

Status unknown Phase 4 Last updated 28 April 2021

What this trial tests

Phase 4 trial testing Intravitreal ranibizumab in Age Related Macular Degeneration in 168 participants. Status unknown.

Timeline

28 February 2017

Primary endpoint
28 February 2024

28 February 2024

Quick facts

Lead sponsor	Unity Health Toronto
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	168
Start date	28 February 2017
Primary completion	28 February 2024
Estimated completion	28 February 2024
Sites	2 locations across Canada

Drugs / interventions tested

• Intravitreal ranibizumab — full drug profile →

Conditions studied

• Age Related Macular Degeneration — all drugs for Age Related Macular Degeneration →
• Diabetic Macular Edema — all drugs for Diabetic Macular Edema →
• Macular Edema — all drugs for Macular Edema →
• Retinal Vein Occlusion — all drugs for Retinal Vein Occlusion →

Sponsor

Unity Health Toronto — full company profile →

Who can join

18 and older, any sex, with Age Related Macular Degeneration or Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Risk Factors and Treatment Strategy for Retinal Vascular Occlusive Diseases.
   Terao R, Fujino R, Ahmed T. · · 2022 · cited 29× · PMID 36362567 · DOI 10.3390/jcm11216340