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

Age-Related Macular Degeneration Clinical Trial

— ATLAS  

Official title:

Optical Coherence Tomography Guided Treat and Extend Therapy for Neovascular Age Related Macular Degeneration Using Aflibercept (the ATLAS Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773954
• Other study ID #: ATLAS
• Secondary ID: 20122054
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2018
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Mid Atlantic Retina- Cherry Hill	Cherry Hill	New Jersey
United States	Mid Atlantic Retina- Huntingdon Valley	Huntingdon Valley	Pennsylvania
United States	Mid Atlantic Retina- Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
MidAtlantic Retina	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Total Thickness at the Foveal Center Point on OCT		Baseline to Week 52
Primary	Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score		Baseline to Week 52