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Monoclonal Antibodies

3 loading doses, then every 2 months for Age-Related Macular Degeneration (ROLL Trial)

Phase 4
Waitlist Available
Led By Brandon G Busbee, MD
Research Sponsored by Tennessee Retina
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 during year 2
Awards & highlights

ROLL Trial Summary

The purpose of this study is to evaluate the efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs.

Eligible Conditions
  • Age-Related Macular Degeneration
  • Pigment Epithelial Detachment

ROLL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during year 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and during year 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Mean Change in Best Corrected Visual Acuity (BCVA)
Mean change in BCVA
Mean change in OCT central retinal thickness
+6 more
Other outcome measures
Incidence and severity of adverse events

Side effects data

From 2015 Phase 4 trial • 26 Patients • NCT01617148
4%
Cataract progression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Group

ROLL Trial Design

1Treatment groups
Experimental Treatment
Group I: 3 loading doses, then every 2 monthsExperimental Treatment1 Intervention
All patients will receive 3 monthly intravitreal aflibercept injections followed by mandatory dosing every 3 months. If needed, patients can be treated monthly.
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?

Tennessee RetinaLead Sponsor
2 Previous Clinical Trials
32 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
620 Previous Clinical Trials
380,355 Total Patients Enrolled
Brandon G Busbee, MDPrincipal InvestigatorTennessee Retina, PC
1 Previous Clinical Trials
37 Total Patients Enrolled

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
On-label tReatment With Intravitreal Aflibercept injectiOn for Patients With Persistent Pigment epitheliaL Detachments in Neovascular Age Related Macular Degeneration (AMD)
2012. "On-label tReatment With Intravitreal Aflibercept injectiOn for Patients With Persistent Pigment epitheliaL Detachments in Neovascular Age Related Macular Degeneration (AMD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01670162.
All > Age Related Macular Degeneration > Macular Degeneration
~2 spots leftby Apr 2025
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