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Monoclonal Antibodies
On-label tReatment With Intravitreal Aflibercept injectiOn for Patients With Persistent Pigment epitheliaL Detachments in Neovascular Age Related Macular Degeneration (AMD) (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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal 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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2015 Phase 4 trial • 26 Patients • NCT016171484%
Cataract progression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Group
Awards & Highlights
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.
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
671 Previous Clinical Trials
385,803 Total Patients Enrolled
Brandon G Busbee, MDPrincipal InvestigatorTennessee Retina, PC
1 Previous Clinical Trials
37 Total Patients Enrolled