Aflibercept in Polypoidal Choroidal Vasculopathy

Neovascular Macular Degeneration Clinical Trial

— PLANET  

Official title:

A Randomized, Double-masked, Sham-controlled Phase 3b/4 Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy as Indicated in Subjects With Polypoidal Choroidal Vasculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120950
• Other study ID #: 16995
• Secondary ID: 2013-004464-54
• Status: Completed
• Phase: Phase 4
• Start date: May 29, 2014
• Est. completion date: July 7, 2017

Study information

• Verified date: November 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: July 7, 2017
• Est. primary completion date: August 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Eylea is administered as an intravitreal injection

Other:
• Visudyne
Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Germany,  Hong Kong,  Hungary,  Japan,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Subjects Who Never Need Rescue Therapy in the First Year	Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.	Baseline to Week 52
Other	Number of PDT Treatments in the Study Eye Before Week 52		Baseline to Week 52
Other	Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52		Baseline to Week 52
Other	Time to First Administration of PDT in the Study Eye Before Week 52		Baseline to Week 52
Other	Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye	Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.	Baseline to Week 52
Other	Percentage of Subjects Who Gained =5, 10, or 15 Letters at Week 52	Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.	Baseline to Week 52
Other	Percentage of Subjects Who Lost =5, 10, or 15 Letters at Week 52	Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.	Baseline to Week 52
Other	Percentage of Subjects With Complete Polyp Regression at Week 52	Complete polyp regression was defined as absent or indeterminate visual polyps on Indocyanine green angiography (ICGA) in the study eye.	Baseline to Week 52
Other	Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52	Leakage is the release of fluorescein dye from diseased retinal vessels. Leakage area is defined as the area showing presence of fluorescein dye in the late stages of fluorescein angiography.	Baseline to Week 52
Other	Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52	Retinal and lesion characteristics, such as central retinal thickness (CRT), were evaluated by OCT in both eyes at every study visit. CRT was measured using optical coherence tomography to determine the average thickness of the retina in a circle with 1 millimeter of diameter centered on the fovea. This value is reported by some OCT devices as central subfield thickness (CST).	Baseline to Week 52
Other	Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52	The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.	Baseline to Week 52
Other	Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52	Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.	Baseline to Week 52
Primary	Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF)	Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.	From Baseline to Week 52
Secondary	Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52	Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.	At Week 52

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