NCT02214628

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 10, 2019

Completed
Last Updated

February 23, 2024

Status Verified

January 1, 2019

Enrollment Period

2.4 years

First QC Date

August 5, 2014

Results QC Date

October 23, 2018

Last Update Submit

February 20, 2024

Conditions

Age-related Macular Degeneration

Keywords

Wet AMDChoroidal neovascularizationFovista®E10030Avastin®Eylea®

Outcome Measures

Primary Outcomes (2)

  • 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)

    2 years

  • Number of Subjects With Serious Adverse Events

    Number of subjects with serious adverse events in each arm

    2 years

Study Arms (2)

Fovista® plus anti-VEGF Simultaneous

EXPERIMENTAL

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

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

Fovista® plus anti-VEGF Pre-Treatment

EXPERIMENTAL

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

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

Interventions

Fovista® (anti-PDGF BB) plus anti-VEGFDRUG
Also known as: Fovista®, anti-VEGF
Fovista® plus anti-VEGF Pre-TreatmentFovista® plus anti-VEGF Simultaneous

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Phoenix, Arizona, 85014, United States

Location

Unknown Facility

Beverly Hills, California, 90211, United States

Location

Unknown Facility

Sacramento, California, 95819, United States

Location

Unknown Facility

Sacramento, California, 95841, United States

Location

Unknown Facility

Santa Ana, California, 92705, United States

Location

Unknown Facility

Augusta, Georgia, 30909, United States

Location

Unknown Facility

Oak Forest, Illinois, 60452, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Jackson, Michigan, 49202, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55435, United States

Location

Unknown Facility

Cincinnati, Ohio, 45242, United States

Location

Unknown Facility

Ladson, South Carolina, 29456, United States

Location

Unknown Facility

Abilene, Texas, 79606, United States

Location

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Keith Westby
Organization
Ophthotech Corp.
keith.westby@ophthotech.com
732-824-7474

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 12, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 23, 2024

Results First Posted

July 10, 2019

Record last verified: 2019-01

Locations

US(13)