Treat and Extend Therapy Study Using Intravitreal Aflibercept for Patients Exited From Protocol VGFT-OD 0910

NCT01961414 | Unknown Phase 4

• 1 other identifier: VGFT-OD-1319
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of aflibercept 2.0mg injections inside the eye for treating patients with Wet Age-related Macular Degeneration.

Conditions

Exudative Age-related Macular Degeneration

Keywords

Exudative; AMD; Macular; Degeneration; Aflibercept; Eylea; Intravitreal

Outcome Measures

Primary Outcomes (1)

• Portion of patients who maintain vision (loss of < or = 5 letters ETDRS BCVA) from baseline to Year 1.

  1 Year

Study Arms (1)

Aflibercept

EXPERIMENTAL

All patients will receive aflibercept 2.0mg intravitreal injection

Drug: Aflibercept

Interventions

Aflibercept DRUG

Patients will receive Aflibercept 2.0mg intravitreal injection at all scheduled study visits

Also known as: Eylea 2.0mg, VEGF TRAP-EYE

Aflibercept

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous enrollment in 0910-extension study evaluating intravitreal aflibercept injection (NCT 00964795) without early study discontinuation prior to sponsor early termination.
• Patients are enrolled within 90 days of site activation (all attempts will be made to ensure IAI is given once exited from the 0910-extension and prior to enrollment).
• Willing and able to comply with clinical visits and study related procedures.
• Provide signed informed consent

You may not qualify if:

• 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
• 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 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 study period
• Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-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, ACIOL, or unstable PCIOL
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
• Pregnant or breast-feeding women
• Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive 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.

Sponsors & Collaborators

• Palmetto Retina Center, LLC: lead

Study Sites (6)

Southeast Retina

Augusta, Georgia, 30909, United States

Location

Eye Surgical Associates

Lincoln, Nebraska, 68506, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Retina Consultants Houston

Houston, Texas, 77030, United States

Location

Rocky Mountain Retina

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• William L. Clark, M.D.

  Palmetto Retina Center, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 30, 2015

Record last verified: 2015-10

Locations

US (6)