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

Age Related Macular Degeneration Clinical Trial

— ROLL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01670162
• Other study ID #: VGFT-OD-1220
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 17, 2012
• Last updated: October 27, 2014
• Start date: August 2012
• Est. completion date: January 2016

Study information

• Verified date: October 2014
• Source: Tennessee Retina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration
• Pigment Epithelial Detachment
• Retinal Detachment

Intervention

Drug:
• Aflibercept
Intravitreal Injection 2mg/0.05mL Aflibercept

Locations

Country	Name	City	State
United States	Retina Associates of Kentucky	Lexington	Kentucky
United States	Tennessee Retina, P.C.	Nashville	Tennessee
United States	Pacific Eye Associates	San Fransisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Tennessee Retina	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence and severity of adverse events		24 month period	Yes
Primary	Proportion of patients with flattening of PED		12 months	No
Secondary	Mean Change in Best Corrected Visual Acuity (BCVA)		6 month timepoint and 12 month timepoints	No
Secondary	Proportion of patients with flattening of PED		6 months	No
Secondary	Proportion of patients with flattening of PED		18 month and 24 month timepoints	No
Secondary	Mean number of injections needed		12 month period	No
Secondary	Mean change in Optical Coherence Tomography (OCT) central retinal thickness		6 month and 12 month timepoints	No
Secondary	Proportion of patients gaining 5 letters or more letters on Early Treatment Diabetic Retinopathy Study (ETDRS) Chart		6 month and 12 month timepoint	No
Secondary	Mean change in BCVA		18 month and 24 month timepoint	No
Secondary	Mean number of injections		during year 2	No
Secondary	Mean change in OCT central retinal thickness		18 month and 24 month timepoints	No
Secondary	Proportion of patients gaining 5 letters or more		18 month and 24 month timepoints	No