Open-label, Non-randomized, Unmasked, Study of IAI in Patients Which Choroidal Neovascularization Secondary to Polypoidal Choroidal Vasculopathy (PCV)
Overview
- Phase
- Phase 4
- Intervention
- Rescue Intravitreal Aflibercept Injection
- Conditions
- Neovascular Polypoidal Choroidal Vasculopathy
- Sponsor
- Southeast Retina Center, Georgia
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence and Severity
- Last Updated
- 11 years ago
Overview
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.
Detailed Description
This is an open-label, non-randomized, unmasked, study of IAI in patients with choroidal neovascularization secondary to polypoidal choroidal vasculopathy (PCV). Twenty treatment naïve and previously treated PCV eyes will be enrolled (only one study eye per patient will be enrolled). A maximum of 10 previously treated eyes will be enrolled. Consented, enrolled patients will be followed monthly. 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. Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met. Starting at Month 3, patients can receive non-anti vascular endothelial growth factor (VEGF) rescue therapy (ie: Photodynamic Therapy (PDT), laser, intravitreal steroids) if the pre-defined criteria are met.
Investigators
Eligibility Criteria
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)
Arms & Interventions
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.
Intervention: Rescue Intravitreal Aflibercept Injection
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.
Intervention: Rescue Therapy with PDT, Laser or Intravitreal Steroids
Outcomes
Primary Outcomes
Incidence and Severity
Time Frame: Month 12
The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 12.
Secondary Outcomes
- Change in Best Corrected Visual Acuity (BCVA)(Months 6 and 12)
- Photography Assessments(Months 6 and 12)