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

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ClinicalTrials.gov Identifier: NCT01773954
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
MidAtlantic Retina, Wills Eye

Tracking Information
First Submitted Date  ICMJE January 17, 2013
First Posted Date  ICMJE January 23, 2013
Results First Submitted Date  ICMJE October 6, 2017
Results First Posted Date  ICMJE May 2, 2018
Last Update Posted Date May 2, 2018
Actual Study Start Date  ICMJE February 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score [ Time Frame: Baseline to Week 52 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
Mean change in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) letter score [ Time Frame: Baseline to Week 52 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
Percentage of eyes with complete resolution of macular fluid on OCT [ Time Frame: Baseline to Week 52 ]
Current Other Pre-specified Outcome Measures
 (submitted: April 30, 2018)
Change in Total Thickness at the Foveal Center Point on OCT [ Time Frame: Baseline to Week 52 ]
Original Other Pre-specified Outcome Measures
 (submitted: January 22, 2013)
Change in total thickness at the foveal center point on OCT [ Time Frame: Baseline to Week 52 ]
 
Descriptive Information
Brief Title  ICMJE Repeated Eye Injections of Aflibercept for Treatment of Wet Age Related Macular Degeneration
Official Title  ICMJE Optical Coherence Tomography Guided Treat and Extend Therapy for Neovascular Age Related Macular Degeneration Using Aflibercept (the ATLAS Study)
Brief Summary 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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Age-Related Macular Degeneration
  • Macular Degeneration
Intervention  ICMJE Drug: Intravitreal Aflibercept Injection
Increased or decreased time between visits
Study Arms  ICMJE Experimental: 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. 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.
Intervention: Drug: Intravitreal Aflibercept Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01773954
Other Study ID Numbers  ICMJE ATLAS
20122054 ( Other Identifier: Western Institutional Review Board )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MidAtlantic Retina, Wills Eye
Study Sponsor  ICMJE MidAtlantic Retina
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Carl Regillo, MD Wills Eye Institute
PRS Account Wills Eye
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP