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.
Information provided by (Responsible Party):
First received: August 17, 2012
Last updated: May 17, 2013
Last verified: May 2013
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.
Age Related Macular Degeneration
Pigment Epithelial Detachment
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||On-label tReatment With Intravitreal Aflibercept Injection for Patients With Persistent Pigment Epithelial Detachments in Neovascular AMD.
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 ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2014 (Final data collection date for primary outcome measure)
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.
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).
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01670162
|Pacific Eye Associates
|San Fransisco, California, United States, 94115 |
|Retina Associates of Kentucky
|Lexington, Kentucky, United States, 40509 |
|Tennessee Retina, P.C.
|Nashville, Tennessee, United States, 37203 |
||Brandon G Busbee, MD
||Tennessee Retina, PC
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 17, 2012
||May 17, 2013
||United States: Institutional Review Board
Keywords provided by Tennessee Retina:
Pigment Epithelium of Eye
Wet macular degeneration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014