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Monoclonal Antibodies
Ranibizumab for Eye Conditions (COVERT Trial)
Phase 4
Waitlist Available
Led By Rajeev Muni
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of active choroidal neovascularization secondary to AMD in the study eye
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 2, visits closest to injection of months 6, 12 and 18
Awards & highlights
COVERT Trial Summary
This trial will examine the association between aqueous cytokine levels and treatment intervals for patients under a variable dosing regimen with intravitreal ranibizumab injections for neovascular age-related macular degeneration, macular edema secondary to retinal vein occlusion, and diabetic macular edema.
Who is the study for?
This trial is for adults with certain eye conditions: active neovascular age-related macular degeneration, macular edema due to retinal vein occlusion, or diabetic macular edema. Participants must have a specific level of central macular thickness and be able to follow the study procedures. Exclusions include recent eye surgery, previous treatments that could affect results, severe vision loss beyond counting fingers, pregnancy, allergies to study drugs or dyes used in diagnosis.Check my eligibility
What is being tested?
The trial tests how baseline levels of certain proteins in the eye fluid (cytokines) relate to treatment frequency with ranibizumab injections. Patients are monitored over time and receive injections based on their condition's response. The study aims to personalize dosing intervals by examining changes in these protein levels after each injection.See study design
What are the potential side effects?
Ranibizumab may cause side effects like redness or discomfort at the injection site, increased intraocular pressure, bleeding inside the eye structure (intraocular hemorrhage), floaters or visual disturbances post-injection. Serious but rare risks include infection within the eyeball (endophthalmitis) and detachment of retina.
COVERT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of vision loss due to AMD in one eye.
Select...
I have diabetes and my eye scan shows swelling in the center of my vision.
Select...
My eye condition is due to swelling in the retina, confirmed by an OCT scan.
COVERT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 2, visits closest to injection of months 6, 12 and 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 2, visits closest to injection of months 6, 12 and 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Association between aqueous cytokine levels and optimal treatment interval
Secondary outcome measures
Average number of injections needed
ETDRS visual acuity change
Individualized relationships between aqueous cytokines and treatment response
+3 moreCOVERT Trial Design
1Treatment groups
Experimental Treatment
Group I: AMD/RVO/DMEExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ranibizumab
FDA approved
Find a Location
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
536 Previous Clinical Trials
447,361 Total Patients Enrolled
7 Trials studying Macular Edema
286 Patients Enrolled for Macular Edema
Rajeev MuniPrincipal InvestigatorUnity Health Toronto
1 Previous Clinical Trials
168 Total Patients Enrolled
1 Trials studying Macular Edema
168 Patients Enrolled for Macular Edema
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had eye inflammation in the eye being studied.You have very poor eyesight, worse than being able to count fingers.I have not had eye injections in the last 6 months.I haven't had eye treatments like photodynamic or laser therapy in the last 6 months.I have diabetes and my eye scan shows swelling in the center of my vision.My eye condition is due to swelling in the retina, confirmed by an OCT scan.I have not had eye surgery in the study eye within the last 3 months.More than half of my eye lesion is covered by large bleeds or scar tissue.I have had eye surgery on the eye being studied.I have a condition affecting the back part of my eye.I haven't had laser eye treatment in the last 6 months.I am on dialysis for kidney failure.I have been diagnosed with a specific type of vision loss due to AMD in one eye.I have active eye disease due to diabetes or had specific laser eye treatment recently.I am currently taking anti-inflammatory or steroid medications.
Research Study Groups:
This trial has the following groups:- Group 1: AMD/RVO/DME
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there remaining vacancies in this research program?
"Evidenced on clinicaltrials.gov, this trial is proactively searching for study participants; with the initial posting occurring on 28th of February 2017 and the most recent update taking place on April 27th 2021."
Answered by AI
How many individuals have signed up for participation in this clinical trial thus far?
"Affirmative, the information available on clinicaltrials.gov attests that this trial is presently searching for test subjects. Initially posted on February 28th 2017, and revised as recently as April 27th 2021, 168 patients are needed to be enrolled from two distinct medical facilities."
Answered by AI
To what extent has this therapeutic intervention been examined in previous research studies?
"Currently, 31 separate experiments are being conducted on this therapy. 15 of these studies have been advanced to Phase 3 and 814 medical centers across the globe are running trials. The majority of them originate in Oak Forest, Illinois."
Answered by AI
What risks do individuals face when undergoing this treatment?
"The security of this treatment is rated a 3 due to it being in Phase 4, which indicates that the intervention has been approved by regulatory bodies."
Answered by AI
What medical conditions is this remedy traditionally used to address?
"Intravitreal injection is used to manage branch vein occlusion, but has also demonstrated efficacy in treating wet age-related macular degeneration (wAMD), macular edema, and myopic choroidal neovascularization."
Answered by AI
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