Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration

Wet Macular Degeneration Clinical Trial

— ALTAIR  

Official title:

A Randomized, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Repeated Doses of Intravitreal Aflibercept With Variable Treatment Intervals in Japanese Subjects With Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305238
• Other study ID #: 17668
• Status: Completed
• Phase: Phase 4
• Start date: December 19, 2014
• Est. completion date: December 20, 2017

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet) Age-related Macular Degeneration (wAMD) .

To assess the safety of IVT administration of aflibercept with two different approaches of Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: December 20, 2017
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Japanese men and women = 50 years of age

• Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD, including juxta-foveal lesions that affect the fovea as evidenced by fluorescein angiography (FA) in the study eye

• Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) of 73 to 25 letters (approximately 20/40 to 20/320 at Snellen equivalent) in the study eye

Exclusion Criteria:

• Prior treatment of the study eye with intraocular anti-VEGF(Vascular Endothelial Growth Factor) agents, verteporfin photodynamic therapy (PDT), other laser, intraocular corticosteroids, surgical interventions (except cataract surgery more than 30 days prior to screening) or systemic use of anti-VEGF products within 3 months prior to study entry

• Active or suspected infection in or surrounding of the study eye

• Active severe intraocular inflammation in the study eye

• Intraocular pressure (IOP) = 25 mmHg in the study eye

• Ocular condition in the study eye which may impact vision and confound study outcomes

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Aflibercept 2mg is intravitreally injected.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Okada AA, Takahashi K, Ohji M, Moon SC, Machewitz T, Sasaki K; ALTAIR Study Investigators. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in the ALTAIR Study: 96-Week Outcomes in the Polypoidal Choroidal Vasculopathy Subgroup. A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in BCVA at Week 52	Visual functions of the study eye (at every visit) and the fellow eye were assessed, according to the ETDRS protocol as described in detail in the operation manual. A higher score represents better functioning.	Baseline and Week 52
Secondary	Percentage of Participants Who Maintained Vision at Week 52	A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.	Week 52
Secondary	Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52		Baseline and Week 52
Secondary	Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52		Baseline and week 52
Secondary	Percentage of Participants Without Fluid on Optical Coherence Tomography (OCT) at Week 52	A participant was classified as without fluid if "Evidence of new or persistent fluid" on OCT was "No".	Week 52

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