Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01961414
Recruitment Status : Unknown
Verified October 2015 by Palmetto Retina Center, LLC.
Recruitment status was:  Active, not recruiting
First Posted : October 11, 2013
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Palmetto Retina Center, LLC

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.

Condition or disease Intervention/treatment Phase
Exudative Age-related Macular Degeneration Drug: Aflibercept Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treat and Extend Therapy Using Intravitreal Aflibercept (IAI) for Previously Treated Patients Exiting the Wet Age-related Macular Degeneration Extension Study (0910)
Study Start Date : October 2013
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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 Name: Eylea 2.0mg, VEGF TRAP-EYE




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961414


Locations
Layout table for location information
United States, Georgia
Southeast Retina
Augusta, Georgia, United States, 30909
United States, Nebraska
Eye Surgical Associates
Lincoln, Nebraska, United States, 68506
United States, South Carolina
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Texas
Retina Consultants Houston
Houston, Texas, United States, 77030
United States, Utah
Rocky Mountain Retina
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Palmetto Retina Center, LLC
Investigators
Layout table for investigator information
Principal Investigator: William L. Clark, M.D. Palmetto Retina Center, LLC

Layout table for additonal information
Responsible Party: Palmetto Retina Center, LLC
ClinicalTrials.gov Identifier: NCT01961414    
Other Study ID Numbers: VGFT-OD-1319
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015
Keywords provided by Palmetto Retina Center, LLC:
Exudative
AMD
Macular
Degeneration
Aflibercept
Eylea
Intravitreal
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases