Phase 4
Completed N=255
Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration
Wet Macular Degeneration
Source: ClinicalTrials.gov NCT02305238 ↗
Enrolled (actual)
255
Serious AEs
16.5%
Results posted
Mar 2018
Primary outcomePrimary: Mean Change From Baseline in BCVA at Week 52 — 9.0; 8.4 letters
◆ Published Evidence
Highly cited
252citations · ~63 / year
Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in the ALTAIR Study: 96-Week Outcomes in the Polypoidal Choroidal Vasculopathy Subgroup.
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.
Linked Publications (3)
-
Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in the ALTAIR Study: 96-Week Outcomes in the Polypoidal Choroidal Vasculopathy Subgroup.
-
Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR : A Randomized Controlled Trial.
-
Relationship between retinal fluid and visual acuity in patients with exudative age-related macular degeneration treated with intravitreal aflibercept using a treat-and-extend regimen: subgroup and post-hoc analyses from the ALTAIR study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in BCVA at Week 52 |
9.0; 8.4 | — |
| SECONDARY Percentage of Participants Who Maintained Vision at Week 52 |
96.7; 95.9 | — |
| SECONDARY Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52 |
32.5; 30.9 | — |
| SECONDARY Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52 |
-134.4; -126.1 | — |
| SECONDARY Percentage of Participants Without Fluid on Optical Coherence Tomography (OCT) at Week 52 |
68.3; 69.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02305238) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.