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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Tennessee Retina
ClinicalTrials.gov Identifier:
NCT01670162
First received: August 17, 2012
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
Pigment Epithelial Detachment
PED
Drug: Aflibercept
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: On-label tReatment With Intravitreal Aflibercept Injection for Patients With Persistent Pigment Epithelial Detachments in Neovascular AMD.

Resource links provided by NLM:


Further study details as provided by Tennessee Retina:

Primary Outcome Measures:
  • Proportion of patients with flattening of PED [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: 6 month timepoint and 12 month timepoints ] [ Designated as safety issue: No ]
  • Proportion of patients with flattening of PED [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients with flattening of PED [ Time Frame: 18 month and 24 month timepoints ] [ Designated as safety issue: No ]
  • Mean number of injections needed [ Time Frame: 12 month period ] [ Designated as safety issue: No ]
  • Mean change in Optical Coherence Tomography (OCT) central retinal thickness [ Time Frame: 6 month and 12 month timepoints ] [ Designated as safety issue: No ]
  • Proportion of patients gaining 5 letters or more letters on Early Treatment Diabetic Retinopathy Study (ETDRS) Chart [ Time Frame: 6 month and 12 month timepoint ] [ Designated as safety issue: No ]
  • Mean change in BCVA [ Time Frame: 18 month and 24 month timepoint ] [ Designated as safety issue: No ]
  • Mean number of injections [ Time Frame: during year 2 ] [ Designated as safety issue: No ]
  • Mean change in OCT central retinal thickness [ Time Frame: 18 month and 24 month timepoints ] [ Designated as safety issue: No ]
  • Proportion of patients gaining 5 letters or more [ Time Frame: 18 month and 24 month timepoints ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: 24 month period ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • VEGF-Trap
  • Eylea

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).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670162

Locations
United States, California
Pacific Eye Associates
San Fransisco, California, United States, 94115
United States, Kentucky
Retina Associates of Kentucky
Lexington, Kentucky, United States, 40509
United States, Tennessee
Tennessee Retina, P.C.
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Tennessee Retina
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Brandon G Busbee, MD Tennessee Retina, PC
  More Information

No publications provided

Responsible Party: Tennessee Retina
ClinicalTrials.gov Identifier: NCT01670162     History of Changes
Other Study ID Numbers: VGFT-OD-1220
Study First Received: August 17, 2012
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tennessee Retina:
Pigment Epithelium of Eye
Wet macular degeneration
Macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Detachment
Dissociative Disorders
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014