Open Label to Study to Evaluate Effect of Alfilbercept on Patients With (FVPED) Fibrovascular Pigment Epithelial Detachment

This study is currently recruiting participants.

Verified June 2012 by Vitreous -Retina- Macula Consultants of New York

Sponsor:

Collaborator:

Regeneron Pharmaceuticals

Information provided by (Responsible Party):

Vitreous -Retina- Macula Consultants of New York

ClinicalTrials.gov Identifier:

NCT01495208

First received: December 15, 2011

Last updated: June 21, 2012

Last verified: June 2012

History of Changes

Purpose

This is an open label study to evaluate the efficacy of intravitreal aflibercept injection 2mg in patients with a persistent FVPED despite at least 6 consecutive injections with ranibizumab 0.5 mg.

Condition	Intervention	Phase
Fibrovascular Pigment Epithelial Detachment	Drug: Aflibercept	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	This is an Open Label Study to Evaluate the Efficacy of Intravitreal Aflibercept Injection 2mg in Patients With a Persistent FVPED Despite at Least 6 Consecutive Injections With Ranibizumab 0.5 mg

Resource links provided by NLM:

Drug Information available for: Aflibercept

U.S. FDA Resources

Further study details as provided by Vitreous -Retina- Macula Consultants of New York:

Primary Outcome Measures:

Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany) [ Time Frame: 24 weeks is the primary end point of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS visual refraction at 4 meters. [ Time Frame: 24 weeks is the primary end point of the study ] [ Designated as safety issue: No ]
- Proportion of patients losing ≤ 15 ETDRS letters compared to baseline.
- Proportion of patients gaining ≥ 5 ETDRS letters compared to baseline.
- Change in sub-RPE tissue characteristics from baseline; determined using EDI-OCT on the Spectralis OCT

Estimated Enrollment:	25
Study Start Date:	December 2011
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Intervention Details:

intravitreal aflibercept injection 2mg

Detailed Description:

This is an open label study to evaluate the efficacy of intravitreal aflibercept injection 2mg in patients with a persistent FVPED despite at least 6 consecutive injections with ranibizumab 0.5 mg.

Patients being evaluated at VRM New York with neovascular AMD who have persistent sub-foveal FVPED on OCT despite at least 6 consecutive ranibizumab injections will be considered for the study.

We aim to recruit 25 patients in the study. There have been no statistical tests to calculate sample size; sample size of 25 patients is chosen, making sure that it is feasible financially to conduct the study and logistically to complete the study within 24 weeks. This is a pilot study to assess the effects of intravitreal aflibercept injection on chronic, persistent FVPEDs; currently there is no data regarding visual and anatomical outcomes for this group of patients.

Patients will be reviewed at baseline and then at 4 week intervals (28 ± 7 days). They will receive intravitreal intravitreal aflibercept injection 2mg at each visit. The primary end point of the study is 24 weeks from baseline. Patients who complete the study will have received 6 injections of intravitreal aflibercept injection 2mg.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age > 50 years
Subfoveal FVPED assessed using clinical examination and OCT
Best corrected visual acuity in the study eye between 20 and 85 letters on the ETDRS chart (20/30 to 20/800 Snellen equivalent)
Prior treatment with at least 6 consecutive injections with ranibizumab 0.5 mg prior to the baseline visit; the last treatment with ranibizumab should not exceed 45 days from the baseline visit.

Exclusion Criteria:

Pregnancy (positive pregnancy test) or lactation
Participation in another simultaneous medical investigation or trial
Prior treatment with ranibizumab therapy in the study eye within 30 days of baseline
Prior treatment with PDT in the study eye
Prior intravitreal injection of a corticosteroid (triamcinolone, dexamethasone) within 120 days from baseline.
Presence of significant subfoveal fibrosis or atrophy determined using SDOCT, fluorescein angiography and clinical examination.
Presence of fibrous or fibrocellular material occupying more than 50% of the sub-RPE space; assessed using EDI OCT
Presence of a RPE tear, determined by clinical examination, FA, FAF and OCT
Intraocular surgery (including cataract surgery) in the study eye within 90 days preceding baseline
History of pars plana vitrectomy, submacular surgery or any other surgical intervention for vitreo-retinal diseases in the study eye
Presence of or previous history of diabetic macular edema or proliferative diabetic retinopathy.
History of uveitis in the study eye
Current vitreous hemorrhage in the study eye
History of rhegmatogenous retinal detachment, macular hole and lamellar hole and in the study eye
Ocular or periocular infection
Active severe intraocular inflammation
Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
In patients with glaucoma, advanced field loss; mean deviation on threshold visual field of more than 12 decibels.
History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
History of allergy to fluorescein, ICG or iodine, not amenable to treatment
Known hypersensitivity to aflibercept or to any of the excipients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495208

Contacts

Contact: May Lee, Coordinator	(212) 452-6965	mlee@vrmny.com
Contact: Nishant Kumar, MD	212 861-9797	nishant6377@googlemail.com

Locations

United States, New York
Vitreous Retina Macula Consultants of New York	Recruiting
New York, New York, United States, 10022
Principal Investigator: Richard F. Spaide, MD

Sponsors and Collaborators

Vitreous -Retina- Macula Consultants of New York

Regeneron Pharmaceuticals

Investigators

Principal Investigator:

Richard Spaide, MD

Vitreous -Retina- Macula Consultants of New York

More Information

No publications provided

Responsible Party:	Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier:	NCT01495208 History of Changes
Other Study ID Numbers:	EVER STUDY
Study First Received:	December 15, 2011
Last Updated:	June 21, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Retinal Detachment
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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