On-label tReatment With Intravitreal Aflibercept injectiOn for Patients With Persistent Pigment epitheliaL Detachments in Neovascular Age Related Macular Degeneration (AMD) (ROLL)

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

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.

Study Overview

• Status: Unknown
• Conditions: Age Related Macular Degeneration; Pigment Epithelial Detachment
• Intervention / Treatment: Drug: Aflibercept

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Fransisco, California, United States, 94115
      • Pacific Eye Associates
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Retina Associates of Kentucky
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Retina, P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 loading doses, then every 2 months; All patients will receive 3 monthly intravitreal aflibercept injections followed by mandatory dosing every 3 months. If needed, patients can be treated monthly.	Drug: Aflibercept; Intravitreal Injection 2mg/0.05mL Aflibercept; Other Names: Eylea; VEGF-Trap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with flattening of PED	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean Change in Best Corrected Visual Acuity (BCVA)	6 month timepoint and 12 month timepoints
Proportion of patients with flattening of PED	6 months
Proportion of patients with flattening of PED	18 month and 24 month timepoints
Mean number of injections needed	12 month period
Mean change in Optical Coherence Tomography (OCT) central retinal thickness	6 month and 12 month timepoints
Proportion of patients gaining 5 letters or more letters on Early Treatment Diabetic Retinopathy Study (ETDRS) Chart	6 month and 12 month timepoint
Mean change in BCVA	18 month and 24 month timepoint
Mean number of injections	during year 2
Mean change in OCT central retinal thickness	18 month and 24 month timepoints
Proportion of patients gaining 5 letters or more	18 month and 24 month timepoints

Other Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events	24 month period

Collaborators and Investigators

• Sponsor: Tennessee Retina
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Principal Investigator: Brandon G Busbee, MD, Tennessee Retina, PC

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: August 17, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (Estimate): August 21, 2012

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 27, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Macular degeneration; Wet macular degeneration; Pigment Epithelium of Eye
• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Retinal Detachment; Dissociative Disorders; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: VGFT-OD-1220