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

• Sponsor: MidAtlantic Retina (Other)
• Overall Status: Completed
• CT.gov ID: NCT01773954
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 40
• Locations: 3
• Arm: 1
• Actual Duration (Months): 36.9
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration; Macular Degeneration	Drug: Intravitreal Aflibercept Injection	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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)
• Actual Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

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.

Drug: Intravitreal Aflibercept Injection; Increased or decreased time between visits

Outcome Measures

Primary Outcome Measures

1. Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score [Baseline to Week 52]

Other Outcome Measures

1. Change in Total Thickness at the Foveal Center Point on OCT [Baseline to Week 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Mid Atlantic Retina- Cherry Hill	Cherry Hill	New Jersey	United States	08002
2	Mid Atlantic Retina- Huntingdon Valley	Huntingdon Valley	Pennsylvania	United States	19006
3	Mid Atlantic Retina- Wills Eye Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• MidAtlantic Retina
• Regeneron Pharmaceuticals

Investigators

• Principal Investigator: Carl Regillo, MD, Wills Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MidAtlantic Retina, Investigator, Wills Eye
• ClinicalTrials.gov Identifier: NCT01773954
• Other Study ID Numbers: ATLAS; 20122054
• First Posted: Jan 23, 2013
• Last Update Posted: May 2, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by MidAtlantic Retina, Investigator, Wills Eye: amd; age related macular degeneration; macular degeneration; neovascular
• Additional relevant MeSH terms: Macular Degeneration; Aflibercept

Study Results

Participant Flow

Arm/Group Title	Intravitreal Aflibercept
Arm/Group Description	Intravitreal aflibercept on treat and extend schedule
Period Title: Overall Study
STARTED	40
COMPLETED	31
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	Intravitreal Aflibercept
Arm/Group Description	Intravitreal aflibercept on treat and extend schedule
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	81.3 (7.4)
Sex: Female, Male (Count of Participants)
Female	23 57.5%
Male	17 42.5%
Region of Enrollment (participants) [Number]
United States	40 100%

Outcome Measures

1. Primary Outcome

Title	Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravitreal Aflibercept
Arm/Group Description	Intravitreal aflibercept on treat and extend schedule
Measure Participants	40
Mean (95% Confidence Interval) [letters]	7.2

2. Other Pre-specified Outcome

Title	Change in Total Thickness at the Foveal Center Point on OCT
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravitreal Aflibercept
Arm/Group Description	Intravitreal aflibercept on treat and extend schedule
Measure Participants	40
Mean (95% Confidence Interval) [micrometers]	-143

Adverse Events

Time Frame	2 years
Arm/Group Title	Intravitreal Aflibercept
Arm/Group Description	Intravitreal aflibercept on treat and extend schedule
All Cause Mortality
	Intravitreal Aflibercept
	Affected / at Risk (%)	# Events
Total	2/40 (5%)
Serious Adverse Events
	Intravitreal Aflibercept
	Affected / at Risk (%)	# Events
Total	2/40 (5%)
Cardiac disorders
Fatal MI	1/40 (2.5%)
Eye disorders
Endophthalmitis	1/40 (2.5%)
Other (Not Including Serious) Adverse Events
	Intravitreal Aflibercept
	Affected / at Risk (%)	# Events
Total	0/40 (0%)

Limitations/Caveats

This is a non-controlled, non-comparative open label study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.