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Monoclonal Antibodies
Aflibercept for Macular Edema (COVARIANT 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, at the visits closest to injection of months 6, 12 and 18.
Awards & highlights
COVARIANT Trial Summary
This trial will test the hypothesis that aflibercept intravitreal injections given on a variable dosing regimen is associated with lower aqueous cytokine levels and longer treatment intervals in patients with 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: neovascular age-related macular degeneration, retinal vein occlusion-caused macular edema, or diabetic macular edema. Participants must have specific levels of central macular thickness and be able to follow the study procedures. Exclusions include recent other treatments for these conditions, severe vision loss, pregnancy, and some other eye or systemic health issues.Check my eligibility
What is being tested?
The trial tests how well intravitreal aflibercept works on a variable dosing schedule in patients with different types of macular problems. It involves regular injections into the eye over an 18-month period with visits that may increase based on treatment response. The study also analyzes cytokine levels in the eye fluid to see if they can predict treatment intervals.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of intravitreal aflibercept can include redness or pain at the injection site, floaters in vision shortly after injection, increased intraocular pressure, and potential risk of infection inside the eye (endophthalmitis).
COVARIANT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have AMD-related vision loss due to abnormal blood vessels.
Select...
I have diabetes and my eye scan shows swelling in the center of my retina.
Select...
My eye condition is due to swelling in the retina with a thickness over 310μm.
COVARIANT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 2, at the visits closest to injection of months 6, 12 and 18.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 2, at the 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 cytokine levels and optimal treatment interval
Secondary outcome measures
Average number of injections needed
Cytokine threshold level with visual and anatomic outcomes
ETDRS visual acuity change
+3 moreCOVARIANT Trial Design
1Treatment groups
Experimental Treatment
Group I: AMD/RVO/DMEExperimental Treatment1 Intervention
Patients presenting to St. Michael's Hospital retina clinic with neovascular AMD, macular edema secondary to retinal vein occlusion and diabetic macular edema treated with intravitreal aflibercept in a variable dosing regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aflibercept
FDA approved
Find a Location
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
540 Previous Clinical Trials
447,612 Total Patients Enrolled
2 Trials studying Retinal Vein Occlusion
348 Patients Enrolled for Retinal Vein Occlusion
Rajeev MuniPrincipal InvestigatorUnity Health Toronto
1 Previous Clinical Trials
168 Total Patients Enrolled
1 Trials studying Retinal Vein Occlusion
168 Patients Enrolled for Retinal Vein Occlusion
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on dialysis for kidney failure.I am currently taking anti-inflammatory or steroid medications.I have AMD-related vision loss due to abnormal blood vessels.My eye condition is due to swelling in the retina with a thickness over 310μm.I have a condition affecting the retina, causing changes to its structure.More than half of my eye lesion is covered by bleeding or scarring.I have diabetes and my eye scan shows swelling in the center of my retina.I have not had eye surgery in the study eye within the last 3 months.I have not had eye injections in the last 6 months.I haven't had laser eye treatment in the last 6 months for RVO.You have very poor eyesight, worse than being able to count fingers.I have had eye surgery on the eye being studied.You are allergic to the study drug or to fluorescein.I have had eye inflammation in the eye being studied.I haven't had eye treatments like photodynamic or laser therapy in the last 6 months.I have active eye disease due to diabetes or had specific laser eye treatment within 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: AMD/RVO/DME
Awards:
This trial has 4 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
How many subjects are participatng in this experiment?
"Indeed, it appears that recruitment is open for this clinical trial. The details of which were first uploaded on February 28th 2017 and last revised April 27th 2021, calling for 168 participants to be enrolled at two different medical centers."
Answered by AI
What safety precautions should patients take before undergoing this treatment regimen?
"This treatment has been assessed to be safe and was given a rating of 3. This is because it has obtained approval as an end-stage clinical trial."
Answered by AI
What type of conditions is this intervention commonly prescribed for?
"Wet age-related macular degeneration (wAMD) is primarily treated with this medication. Additionally, it can be used to ameliorate symptoms of other conditions including Macular edema, Diabetic Macular Edema (DME), and Macular Degeneration."
Answered by AI
Are there any spots available to join this research endeavor?
"Affirmative. Clinicaltrials.gov details that the clinical trial is currently recruiting, with its initial posting on February 28th 2017 and latest revision occurring April 27th 2021. 168 participants will be accepted from 2 medical centres."
Answered by AI
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