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

NCT01773954 | Completed Results DMC

• 2 other identifiers: ATLAS20122054
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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).

Conditions

Age-Related Macular Degeneration; Macular Degeneration

Keywords

amd; age related macular degeneration; macular degeneration; neovascular

Outcome Measures

Primary Outcomes (1)

• Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score

  Baseline to Week 52

Other Outcomes (1)

• Change in Total Thickness at the Foveal Center Point on OCT

  Baseline to Week 52

Study Arms (1)

Intravitreal Aflibercept Injection More

EXPERIMENTAL

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

Interventions

Intravitreal Aflibercept Injection DRUG

Increased or decreased time between visits

Intravitreal Aflibercept Injection More

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• MidAtlantic Retina: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (3)

Mid Atlantic Retina- Cherry Hill

Cherry Hill, New Jersey, 08002, United States

Location

Mid Atlantic Retina- Huntingdon Valley

Huntingdon Valley, Pennsylvania, 19006, United States

Location

Mid Atlantic Retina- Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Glycogen Storage Disease Type II

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glycogen Storage Disease; Carbohydrate Metabolism, Inborn Errors; Lysosomal Storage Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Michele Formoso
• Organization: Mid Atlantic Retina

research@midatlanticretina.com

215-928-3092

Study Officials

• Carl Regillo, MD

  Wills Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 23, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 2, 2018
• Results First Posted: May 2, 2018

Record last verified: 2018-04

Locations

US (3)