Trial record 8 of 1005 for:    "Macular degeneration"

Repeated Eye Injections of Aflibercept for Treatment of Wet Age Related Macular Degeneration (ATLAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Brian Burke, MPH, Wills Eye
ClinicalTrials.gov Identifier:
NCT01773954
First received: January 17, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

To evaluate the visual outcome and number of injections required during an optical coherence tomography (OCT)-guided treat and extend regimen with intravitreal aflibercept for treatment of subfoveal neovascular age-related macular degeneration (NVAMD).


Condition Intervention
Age-Related Macular Degeneration
Macular Degeneration
Drug: Intravitreal Aflibercept Injection More
Drug: Intravitreal Aflibercept Injection Less

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optical Coherence Tomography Guided Treat and Extend Therapy for Neovascular Age Related Macular Degeneration Using Aflibercept (the ATLAS Study)

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Mean change in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) letter score [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of eyes with complete resolution of macular fluid on OCT [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in total thickness at the foveal center point on OCT [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intravitreal Aflibercept Injection More
Patient receives treatment at baseline and week 4 visit. The first time extension criteria are met the follow-up interval will be increased by 4 weeks. Each time the extension criteria is met the interval will be extended by 2 weeks to a maximum of 16 weeks.
Drug: Intravitreal Aflibercept Injection More
Increased time between visits
Drug: Intravitreal Aflibercept Injection Less
Reduced time between visits
Active Comparator: Intravitreal Aflibercept Injection Less
Patient receives treatment at baseline and week 4 visit. The first time extension criteria are met the follow-up interval will be increased by 4 weeks. If a patient is being followed at an 8 week interval but fails to meet extension criteria at a particular visit, treatment will be administered as usual and the follow up interval will be reduced to 4 weeks. If patient is being followed at 10-16 week interval but fails to meet extension criteria at a particular visit, treatment will be administered but the follow-up interval will be reduced by 2 week increments.
Drug: Intravitreal Aflibercept Injection More
Increased time between visits
Drug: Intravitreal Aflibercept Injection Less
Reduced time between visits

Detailed Description:

The purpose of this study is to see how using "treat and extend," a method of determining how often a patient with NVAMD should visit the retina clinic and receive treatments, affects vision in patients with this condition after treatment. The treatment the investigators are using in this study is an eye injection of a drug called aflibercept (also called EYLEA). Eylea is FDA (Food and Drug Administration) approved for treatment of wet age related macular degeneration.

The investigators hope that "treat and extend" strikes the right balance between making sure patients get all of the treatments needed, but not giving patients too many treatments (so that the side effects of treatments are minimized and so that patients don't have to make more visits than they need to maintain maximum visual gain). The experimental part of this study is determining this "right balance" of eye injections.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 55 years with treatment naïve, active subfoveal NVAMD demonstrating macular fluid on optical coherence tomography (OCT) and leakage on fluorescein angiography (FA).
  • Only one eye for each patient demonstrating a pre-treatment acuity of 20/25 - 20/320 is eligible
  • Patients cannot have concurrent progressive retinal disease in the study eye.
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

Exclusion Criteria:

  • Prior treatment for NVAMD in the study eye,
  • Prior experimental treatment of NVAMD in either eye
  • Prior treatment with systemic anti-VEGF (vascular endothelial growth factor) agents
  • Prior treatment with verteporfin, plaque brachytherapy, 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 vitreo surgical intervention in the study eye. Cataract surgery is permitted.
  • 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 52 weeks study period to prevent or treat visual loss that might result from that condition, or
  • allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 52 weeks 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, Anterior Chamber Intraocular Lens (ACIOL), or unstable Posterior Chamber Intraocular Lens (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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773954

Locations
United States, New Jersey
Mid Atlantic Retina- Cherry Hill
Cherry Hill, New Jersey, United States, 08002
United States, Pennsylvania
Mid Atlantic Retina- Huntingdon Valley
Huntingdon Valley, Pennsylvania, United States, 19006
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Brian Burke, MPH
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Carl Regillo, MD Wills Eye Institute
  More Information

No publications provided

Responsible Party: Brian Burke, MPH, Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01773954     History of Changes
Other Study ID Numbers: ATLAS, 20122054
Study First Received: January 17, 2013
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Wills Eye:
amd
age related macular degeneration
macular degeneration
neovascular

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 24, 2014