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

Primary Purpose

Fibrovascular Pigment Epithelial Detachment

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aflibercept

About this trial

This is an interventional treatment trial for Fibrovascular Pigment Epithelial Detachment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vitreous Retina Macula Consultants of New York

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

aflibercept

Arm Description

Outcomes

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)

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

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)

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)

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.

Secondary Outcome Measures

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

Proportion of patients losing ≤ 15 ETDRS letters compared to baseline. Proportion of patients gaining ≥ 5 ETDRS letters compared to baseline.

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

Measure the Change in sub-RPE tissue characteristics from baseline; determined using EDI-OCT on the Spectralis OCT

Full Information

NCT ID

NCT01495208

First Posted

December 15, 2011

Last Updated

July 12, 2018

Sponsor

Vitreous -Retina- Macula Consultants of New York

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01495208

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Withdrawn

Study Start Date

December 2011 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vitreous -Retina- Macula Consultants of New York

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibrovascular Pigment Epithelial Detachment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

aflibercept

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Aflibercept

Intervention Description

intravitreal aflibercept injection 2mg

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

24 weeks is the primary end point of the study

Title

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

Description

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

Time Frame

24 weeks is the primary end point of the study

Title

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

Description

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)

Time Frame

24 weeks is the primary end point of the study

Title

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

Description

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

Time Frame

24 weeks is the primary end point of the study

Secondary Outcome Measure Information:

Title

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

Description

Proportion of patients losing ≤ 15 ETDRS letters compared to baseline. Proportion of patients gaining ≥ 5 ETDRS letters compared to baseline.

Time Frame

24 weeks is the primary end point of the study

Title

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

Description

Measure the Change in sub-RPE tissue characteristics from baseline; determined using EDI-OCT on the Spectralis OCT

Time Frame

24 weeks is the primary end point of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Spaide, MD

Organizational Affiliation

Vitreous -Retina- Macula Consultants of New York

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vitreous Retina Macula Consultants of New York

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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