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Anti-VEGF

aflibercept for Age-Related Macular Degeneration (PRaCTICAL Trial)

Phase 4
Waitlist Available
Led By Radha P. Kohly, MD PhD FRCSC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months from baseline intervention
Awards & highlights

PRaCTICAL Trial Summary

This trial is comparing cytokine profiles in nAMD, CSR and iPCV to see if there are differences that could help with diagnosis.

Eligible Conditions
  • Idiopathic Polypoidal Choroidal Vasculopathy
  • Age-Related Macular Degeneration
  • Central Serous Retinopathy

PRaCTICAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months from baseline intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months from baseline intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline aqueous humour cytokine levels in nAMD, CSR, and iPCV patients
Secondary outcome measures
Assessment of the intra-group changes in anatomical changes via OCT imaging from baseline after aflibercept treatment in patients with nAMD, CSR, and iPCV for 4 months
Assessment of the intra-group changes in best-corrected visual acuity using Snellen eye charts after aflibercept treatment in patients with nAMD, CSR, and iPCV for 4 months

Side effects data

From 2020 Phase 4 trial • 20 Patients • NCT02559180
5%
Hypertension and Hyperglycemia
5%
Chest pain
5%
Bilateral lower limb cellulitis
5%
Death of unknown cause
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

PRaCTICAL Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: iPCV group with PEDExperimental Treatment1 Intervention
Patients in this group will be administered aflibercept intravitreal injection 2 mg (0.05 mL), administered at baseline, month 1, and month 2, for a total of 3 injections. Study will end for these patients at month 4, where no injection will be given. A clinical exam and OCT imaging will be performed each visit.
Group II: CSR group with PEDExperimental Treatment1 Intervention
Patients in this group will be administered aflibercept intravitreal injection 2 mg (0.05 mL), administered at baseline, month 1, and month 2, for a total of 3 injections. Study will end for these patients at month 4, where no injection will be given. A clinical exam and OCT imaging will be performed each visit.
Group III: neovascular AMD group with PEDActive Control1 Intervention
Patients in this group will be administered aflibercept intravitreal injection 2 mg (0.05 mL), administered at baseline, month 1, and month 2, for a total of 3 injections. Study will end for these patients at month 4, where no injection will be given. A clinical exam and OCT imaging will be performed each visit.
Group IV: cataract patientsActive Control1 Intervention
Patients diagnosed with cataracts requiring cataract surgery will serve as study controls. No intervention will be applied to these patients.
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?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,587 Total Patients Enrolled
Radha P. Kohly, MD PhD FRCSCPrincipal InvestigatorSunnybrook Health Sciences Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PRedictive Factors and Changes From Treatment in iPCV Versus CSR Versus nAMD With afLibercept
Dr. Radha Kohly 2018. "PRedictive Factors and Changes From Treatment in iPCV Versus CSR Versus nAMD With afLibercept". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02681783.
~14 spots leftby Apr 2025
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