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

Treat and Extend Therapy Using Intravitreal Aflibercept (IAI) for Previously Treated Patients Exiting the Wet Age-related Macular Degeneration Extension Study (0910)

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.

Study Overview

• Status: Unknown
• Conditions: Exudative Age-related Macular Degeneration
• Intervention / Treatment: Drug: Aflibercept

Detailed Description

After exiting VGFT-OD 0910, patients will be enrolled into RANGE, a longterm extension trial evaluating the safety and efficacy of aflibercept IAI utilizing a "treat and extend" regimen. Using pre-specified re-treatment criteria, treatment intervals will be variable with dosing of the active treatment at least every 12 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Eye Surgical Associates
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Palmetto Retina Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Retina Consultants Houston
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Rocky Mountain Retina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

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

• 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.

    • 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aflibercept; All patients will receive aflibercept 2.0mg intravitreal injection	Drug: Aflibercept; Patients will receive Aflibercept 2.0mg intravitreal injection at all scheduled study visits; Other Names: Eylea 2.0mg, VEGF TRAP-EYE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Palmetto Retina Center, LLC
• Investigators: Principal Investigator: William L. Clark, M.D., Palmetto Retina Center, LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Estimate): October 30, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: AMD; Eylea; Aflibercept; Intravitreal; Macular; Exudative; Degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: VGFT-OD-1319