NCT02092532

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

March 13, 2014

Last Update Submit

October 14, 2014

Conditions

Neovascular Polypoidal Choroidal Vasculopathy

Outcome Measures

Primary Outcomes (2)

  • Incidence and Severity

    The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 6.

    Month 6

  • Incidence and Severity

    The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 12.

    Month 12

Secondary Outcomes (10)

  • Change in Best Corrected Visual Acuity (BCVA)

    Months 6 and 12

  • Change in Best Corrected Visual Acuity (BCVA)

    Months 6 and 12

  • Change in Best Corrected Visual Acuity (BCVA)

    Months 6 and 12

  • Photography Assessments

    Months 6 and 12

  • Photography Assessments

    Months 6 and 12

  • +5 more secondary outcomes

Other Outcomes (3)

  • Rescue Therapy

    Month 12

  • Rescue Therapy

    Month 12

  • Rescue Therapy

    Month 12

Study Arms (1)

Intravitreal Aflibercept Injection

OTHER

All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months.

Drug: Rescue Intravitreal Aflibercept InjectionProcedure: Rescue Therapy with PDT, Laser or Intravitreal Steroids

Interventions

Rescue Intravitreal Aflibercept InjectionDRUG

Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met.

Intravitreal Aflibercept Injection
Rescue Therapy with PDT, Laser or Intravitreal SteroidsPROCEDURE

Starting at Month 3, patients can receive non-anti VEGF rescue therapy (ie: PDT, laser, intravitreal steroids) if the pre-defined criteria are met.

Intravitreal Aflibercept Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females ≥ 18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control
  • ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid
  • Best corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity at 4 meters between 20/20 - 20/400 (BCVA ETDRS letter score 85 - 20 letters in the study eye)
  • Lesion Characteristics - leaking lesions consistent with PCV. (No limitations on hemorrhage, fibrosis or atrophy)
  • Clear ocular media to allow for photography/angiography
  • Willing and able to comply with clinic visits and study-related procedures
  • Patients with bilateral disease will only be able to enroll one eye
  • Provide signed informed consent

You may not qualify if:

  • Any history of systemic Anti-VEGF therapy
  • Current ocular or periocular infection
  • Active intraocular inflammation
  • Any comorbid condition that may decrease visual acuity
  • Any patients who have had intraocular surgery within the past 30 days for any condition
  • For treatment naïve patients: No prior anti-VEGF, PDT, intravitreal steroids or laser (subfoveal or non foveal)
  • For previously-treated patients :
  • Prior anti-VEGF (ranibizumab, bevacizumab, pegaptanib) within 30 days
  • Prior IAI
  • Prior PDT , transpupillary thermal therapy (TTT) or radiation within 90 days (a maximum of 3 PDTs allowed)
  • Prior intravitreal steroids within 90 days
  • Prior non-foveal laser within 90 days
  • Prior subfoveal laser
  • Patients with features of dry age-related macular degeneration such as abundant drusen and symptoms/demographic features inconsistent with the diagnosis of PCV
  • Allergy to fluorescein, ICG, iodine, shellfish
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast Retina Center, PC

Augusta, Georgia, 30909, United States

RECRUITING

MeSH Terms

Interventions

1-phenyl-3,3-dimethyltriazeneLasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Dennis M Marcus, MD

    Part-Owner of Southeast Retina Center, PC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Siobhan Ortiz

CONTACT

706-650-0061siobhan@southeastretina.com

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

March 13, 2014

First Posted

March 20, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

US(1)