Aflibercept in Polypoidal Choroidal Vasculopathy (PLANET)

Bayer

Status and phase: Completed; Phase 4

Conditions: Neovascular Macular Degeneration

Treatments: Other: Visudyne; Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02120950

16995

2013-004464-54 (EudraCT Number)

Details and patient eligibility

About

To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration

Enrollment: 333 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Men and women ≥50 years of age
• Diagnosis of symptomatic macular Polypoidal Choroidal Vasculopathy (PCV) in the study eye established by Indocyanine Green Angiography(ICGA) at the study center
• Greatest linear dimension of the lesion of < 5400 mm (approximately, 9 Macular Photocoagulation Study disk areas), assessed by ICGA.
• An Early treatment diabetic retinopathy study (ETDRS) BCVA of 73 to 24 letters in the study eye.

Exclusion criteria

• Prior use of intravitreal or sub-tenon corticosteroids in the study eye within 3 months prior to study entry
• Any prior use of intraocular anti Vascular Endothelial Growth Factor (anti-VEGF)agents in the study eye, or systemic use of anti VEGF products within 3 months prior to study entry
• Prior macular laser treatment in the study eye including Photodynamic Therapy (PDT)
• History of allergy to fluorescein used in fluorescein angiography, iodine and/or indocyanine green.
• History of allergy to aflibercept, verteporfin, or their excipients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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333 participants in 2 patient groups

Aflibercept + Sham PDT

Experimental group

Description:

Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy)

Treatment:

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Aflibercept + Active PDT

Experimental group

Description:

Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy)

Treatment:

Other: Visudyne

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)