Clinical trial NCT01670162: On-label tReatment With Intravitreal Aflibercept injectiOn for Patients With Persistent Pigment epitheliaL Detachments in Neovascular Age Related Macular Degeneration (AMD)
Official title: On-label tReatment With Intravitreal Aflibercept Injection for Patients With Persistent Pigment Epithelial Detachments in Neovascular AMD.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Age Related Macular Degeneration
Pigment Epithelial Detachment
Keywords: Pigment Epithelium of Eye
Wet macular degeneration
Macular degeneration
Lead sponsor: Tennessee Retina
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2012-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Proportion of patients with flattening of PED
timeFrame: 12 months
Secondary outcomes:
measure: Mean Change in Best Corrected Visual Acuity (BCVA)
timeFrame: 6 month timepoint and 12 month timepoints
measure: Proportion of patients with flattening of PED
timeFrame: 6 months
measure: Proportion of patients with flattening of PED
timeFrame: 18 month and 24 month timepoints
measure: Mean number of injections needed
timeFrame: 12 month period
measure: Mean change in Optical Coherence Tomography (OCT) central retinal thickness
timeFrame: 6 month and 12 month timepoints
measure: Proportion of patients gaining 5 letters or more letters on Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
timeFrame: 6 month and 12 month timepoint
measure: Mean change in BCVA
timeFrame: 18 month and 24 month timepoint
measure: Mean number of injections
timeFrame: during year 2
measure: Mean change in OCT central retinal thickness
timeFrame: 18 month and 24 month timepoints
measure: Proportion of patients gaining 5 letters or more
timeFrame: 18 month and 24 month timepoints
Other outcomes:
measure: Incidence and severity of adverse events
timeFrame: 24 month period
Locations:
city: San Fransisco
country: United States
facility: Pacific Eye Associates
state: California
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Nashville
country: United States
facility: Tennessee Retina, P.C.
state: Tennessee
Study officials:
affiliation: Tennessee Retina, PC
name: Brandon G Busbee, MD
role: PRINCIPAL_INVESTIGATOR
References: