ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02305238
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

November 28, 2014
December 2, 2014
December 14, 2017
March 12, 2018
March 12, 2018
December 19, 2014
December 22, 2016   (Final data collection date for primary outcome measure)
Mean Change From Baseline in BCVA at Week 52 [ Time Frame: Baseline and Week 52 ]
Visual functions of the study eye (at every visit) were assessed, according to the ETDRS protocol as described in detail in the operation manual. A higher score represents better functioning.
Mean change from baseline in best-corrected visual acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score at week 52 [ Time Frame: Baseline and Week 52 ]
Complete list of historical versions of study NCT02305238 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Who Maintained Vision at Week 52 [ Time Frame: 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.
  • Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52 [ Time Frame: Baseline and Week 52 ]
  • Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52 [ Time Frame: Baseline and week 52 ]
  • Percentage of Participants Without Fluid on Optical Coherence Tomography (OCT) at Week 52 [ Time Frame: Week 52 ]
    Retinal and lesion characteristics were evaluated, using OCT, for the study eye at every visit. A participant was classified as without fluid if "Evidence of new or persistent fluid" on OCT was "No".
  • Proportion of subjects who maintain vision at Week 52 [ Time Frame: Baseline and Week 52 ]
    Subject is classified as maintaining vision if the subject has lost fewer than 15 letters in the ETDRS letter score compared to baseline (i.e., prevention of moderate vision loss).
  • Proportion of subjects who gain at least 15 letters of vision compared to baseline at Week 52 [ Time Frame: Baseline and Week 52 ]
  • Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52 [ Time Frame: Baseline and week 52 ]
  • Proportion of subjects without fluid on Optical coherence tomography (OCT) at Week 52 [ Time Frame: Week 52 ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: up to 2 years ]
Not Provided
Not Provided
 
Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Wet Macular Degeneration
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Aflibercept 2mg is intravitreally injected.
  • Experimental: 2 Weeks adjustment
    Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
    Intervention: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
  • Experimental: 4 Weeks adjustment
    Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
    Intervention: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
250
December 20, 2017
December 22, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT02305238
17668
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Not Provided
Bayer
Bayer
Regeneron Pharmaceuticals
Study Director: Bayer Study Director Bayer
Bayer
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP