Recruiting

Aflibercept

Sponsor:

Southeast Retina Center, Georgia

Code:

NCT02092532

Conditions

Neovascular Polypoidal Choroidal Vasculopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Rescue Intravitreal Aflibercept Injection

Rescue Therapy with PDT, Laser or Intravitreal Steroids

Study Details

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.

Conditions

Neovascular Polypoidal Choroidal Vasculopathy

Study ID

NCT02092532

Start date

Mar, 2014

Status verified date

Oct, 2014

Completion date

Mar, 2016

Anticipated

Primary completion date

Mar, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Any other condition that the investigator believes would pose a significant hazard to the patient if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
  • History of previous subfoveal laser
  • Advanced glaucoma (IOP > 25 or cup/disc ratio > 0.8)
  • Pregnant or breast-feeding women
  • Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) \*Contraception is not required for men with documented vasectomy. \*\*Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Intravitreal Aflibercept Injection

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.

Interventions

Rescue Intravitreal Aflibercept Injection

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

Rescue Therapy with PDT, Laser or Intravitreal Steroids

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

Primary outcome measure

  • Incidence and Severity [ Time Frame: Month 6 ]
  • Incidence and Severity [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Siobhan Ortiz

706-650-0061siobhan@southeastretina.com

Locations

Southeast Retina Center, PC

Recruiting

Augusta, Georgia, United States, 30909

Contacts

Dennis M Marcus, MD

706-650-0061dmarcus@southeastretina.com

Jared Gardner, BS

706-650-0061jgardner@southeastretina.com

Principal Investigator:

Dennis M Marcus, MD

More Information

Sponsor

Southeast Retina Center, Georgia

Last update posted

Oct 15, 2014

Last verified

Oct, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southeast Retina Center, Georgia on 2014-10-15.