Suspended

ROLLOn-label tReatment With Intravitreal Aflibercept Injection for Patients With Persistent Pigment Epithelial Detachments in Neovascular AMD.

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What is being tested

Aflibercept

Drug
Who is being recruted

Eye Diseases+3

+ Retinal Degeneration

+ Retinal Diseases

Over 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorTennessee Retina
Last updated: October 29, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

A Phase 4 study 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 (the ROLL study).

Principal SponsorTennessee Retina
Last updated: October 29, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesRetinal DegenerationRetinal DiseasesMacular DegenerationRetinal DetachmentWet Macular Degeneration

Criteria

Inclusion Criteria: Previous enrollment in the study evaluating 2.0mg ranibizumab (NCT 01189019) without early study discontinuation. The last treatment* in the study eye should have been received at least 30 days before enrollment in this study. **last study treatment of either 1.0mg or 2.0mg ranibizumab Presence of persistent fibrovascular pigment epithelial detachment Willing and able to comply iwth clinic visits and study related procedures Provide signed informed consent Exclusion Criteria: Prior treatment with verteporfin, or external beam radiation therapy, or transpupillary thermotherapy in the study eye. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye. History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye. Concurrent eye disease in the study eye that could compromise visual acuity (e.g. diabetic retinopathy, advanced glaucoma). Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either require medical or surgical intervention during the 12 month study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 12 month study period. Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or auto-immune associated uveitis in either eye. Current vitreous hemorrhage in the study eye. History of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the study eye. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye. Aphakia, anterior chamber intraocular lens (ACIOL) or unstable posterior chamber intraocular lens (PCIOL). Uncontrolled glaucoma in the study eye (defined as intraocular pressure equal to or greater than 30 despite treatment with anti-glaucoma medication). Pregnant or breastfeeding women. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraception measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam or jelly). Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All patients will receive 3 monthly intravitreal aflibercept injections followed by mandatory dosing every 3 months. If needed, patients can be treated monthly.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Pacific Eye Associates

San Francisco, United StatesOpen Pacific Eye Associates in Google Maps

Retina Associates of Kentucky

Lexington, United States

Tennessee Retina, P.C.

Nashville, United States
Suspended3 Study Centers