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

This study has been completed.
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: August 1, 2013
Last verified: August 2013
  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:


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


Enrollment: 6
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aflibercept Drug: Aflibercept
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Vitreous Retina Macula Consultants of New York
New York, New York, United States, 10022
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: August 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 26, 2014