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Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD

Primary Purpose

Age-related Macular Degeneration

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fovista® (anti-PDGF BB) plus anti-VEGF

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring Wet AMD, Choroidal neovascularization, Fovista®, E10030, Avastin®, Eylea®

Eligibility Criteria

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

Inclusion Criteria:

Subjects of either gender aged ≥ 50 years
All fluorescein angiographic subtypes with presence of active choroidal neovascularization

Exclusion Criteria:

Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
Subjects with subfoveal scar or subfoveal atrophy
Any ocular or periocular infection in the past twelve (12) weeks
History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Fovista® plus anti-VEGF Simultaneous

Fovista® plus anti-VEGF Pre-Treatment

Arm Description

Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration.

Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration.

Outcomes

Primary Outcome Measures

Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)

Number of subjects on either arm with non-serious adverse events (reported by >5% of subjects)

Number of Subjects With Serious Adverse Events

Number of subjects with serious adverse events in each arm

Secondary Outcome Measures

Full Information

NCT ID

NCT02214628

First Posted

August 5, 2014

Last Updated

June 18, 2019

Sponsor

Ophthotech Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02214628

Brief Title

Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD

Official Title

A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the Induction and Maintenance Phase of Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Terminated

Study Start Date

July 2014 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ophthotech Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.

Detailed Description

The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).

6. Conditions and Keywords

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

Age-related Macular Degeneration

Keywords

Wet AMD, Choroidal neovascularization, Fovista®, E10030, Avastin®, Eylea®

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fovista® plus anti-VEGF Simultaneous

Arm Type

Experimental

Arm Description

Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration.

Arm Title

Fovista® plus anti-VEGF Pre-Treatment

Arm Type

Experimental

Arm Description

Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration.

Intervention Type

Drug

Intervention Name(s)

Fovista® (anti-PDGF BB) plus anti-VEGF

Other Intervention Name(s)

Fovista®, anti-VEGF

Primary Outcome Measure Information:

Title

Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)

Description

Number of subjects on either arm with non-serious adverse events (reported by >5% of subjects)

Time Frame

2 years

Title

Number of Subjects With Serious Adverse Events

Description

Number of subjects with serious adverse events in each arm

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects of either gender aged ≥ 50 years All fluorescein angiographic subtypes with presence of active choroidal neovascularization Exclusion Criteria: Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication Subjects with subfoveal scar or subfoveal atrophy Any ocular or periocular infection in the past twelve (12) weeks History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant

Facility Information:

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85014

Country

United States

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

City

Sacramento

State/Province

California

ZIP/Postal Code

95819

Country

United States

City

Sacramento

State/Province

California

ZIP/Postal Code

95841

Country

United States

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

City

Oak Forest

State/Province

Illinois

ZIP/Postal Code

60452

Country

United States

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

City

Jackson

State/Province

Michigan

ZIP/Postal Code

49202

Country

United States

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

City

Ladson

State/Province

South Carolina

ZIP/Postal Code

29456

Country

United States

City

Abilene

State/Province

Texas

ZIP/Postal Code

79606

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD

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