Comparison of Treatment rOutine Using afLibERcept: Strict vs relAxed retreatmeNT Regimen

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT02550002
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The primary objective of this study is to test non-inferiority of aflibercept "treat and extend" using a relaxed retinal fluid management relative to aflibercept "treat and extend" using a strict retinal fluid management SD-OCT (spectral domain optical coherence tomography) disease activity guided retreatment with respect to best-corrected visual acuity (BCVA) from baseline to end of treatment.

Key Dates

Start date
Dec 31, 2015
Status verified
Nov 2022
Primary completion
Mar 31, 2022
Completion
Aug 31, 2022

Study Design

Enrollment
150 participants (actual)

Arms

  • Arm: Strict treatment regimen with aflibercept
    Treatment intervals with aflibercept in the strict retinal fluid treatment regimen will be extended by two weeks only if no SRF in the central subfoveal field and no IRF can be detected SD-OCT examination.
  • Arm: Relaxed treatment regimen with aflibercept
    Treatment intervals with aflibercept in the relaxed retinal fluid treatment regimen will be extended by two weeks only if SRF in the central subfoveal field is ≤100 μm in a vertical extent and no IRF is detected on SD-OCT examination.

Primary Outcome Measure

Change in best corrected visual acuity (BCVA) from baseline to end of treatment (EOS) at week 104. The primary outcome of the trial is the difference between the two arms in the mean change in BCVA from baseline to EOS. [ Time Frame: From baseline to 24 months ]

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