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

NCT01495208 | Withdrawn Phase 4

• 1 other identifier: EVER STUDY
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibrovascular Pigment Epithelial Detachment

Outcome Measures

Primary Outcomes (4)

• Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)

  Using the Heidelberg software, subfoveal subretinal fluid (distance between the IS/OS line and the RPE line on SDOCT)

  24 weeks is the primary end point of the study

• Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)

  Measure of retinal volume (distance between the ILM and RPE outer margin on SDOCT)

  24 weeks is the primary end point of the study

• Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)

  Measure of PED height (distance between ILM and Bruchs membrane (if visible) or the horizontal line where the RPE should be present if it was not elevated)

  24 weeks is the primary end point of the study

• Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)

  Measure of maximal diameter of the PED (measured as the point from where the RPE detachment begins to where it ends) will be measured.

  24 weeks is the primary end point of the study

Secondary Outcomes (2)

• Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS visual refraction at 4 meters.

  24 weeks is the primary end point of the study

• Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS

  24 weeks is the primary end point of the study

Study Arms (1)

aflibercept

EXPERIMENTAL

Drug: Aflibercept

Interventions

Aflibercept DRUG

intravitreal aflibercept injection 2mg

aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vitreous -Retina- Macula Consultants of New York: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Vitreous Retina Macula Consultants of New York

New York, New York, 10022, United States

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Richard Spaide, MD

  Vitreous -Retina- Macula Consultants of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 19, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 16, 2018

Record last verified: 2018-05

Locations

US (1)