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Tolerating Subretinal Fluid in Neovascular Age-Related Macular Degeneration Treated with Ranibizumab Using a Treat-and-Extend Regimen (FLUID)
May, 2019
Clinical Trial
Tolerating Subretinal Fluid in Neovascular Age-Related Macular Degeneration Treated with Ranibizumab Using a Treat-and-Extend Regimen: FLUID Study 24-Month Results.
Guymer RH, Markey CM, McAllister IL, Gillies MC, Hunyor AP, Arnold JJ.
Main finding: Patients treated with a ranibizumab treat-and-extend protocol who tolerated some subretinal fluid (SRF) achieved visual acuity that is comparable, with fewer injections, with that achieved when treatment aimed to resolve all SRF completely.
- Purpose: To evaluate the hypothesis that tolerating some subretinal fluid in patients with nAMD treated with ranibizumab using a treat-and-extend (T&E) regimen can achieve similar visual acuity outcomes as treatment aimed at resolving all SRF.
- Study type: Randomized controlled Trial
- Condition: Neovascular AMD
Participants: treatment-naïve active subfoveal CNV secondary to AMD
- n=279
Intervention:
Group 1 (intensive arm): Ranibizumab 0.5mg monthly until complete resolution of SRF and intraretinal fluid
Group 2 (relaxed arm): Ranibizumab 0.5mg monthly until resolution of intraretinal fluid only before extending treamtent intervals
The relaxed treatment arm demonstrated non-inferior BCVA improvement from baseline to month 24 compared with the intensive treatment arm.
Participants in the relaxed group received fewer ranibizumab injections over 24 months than those in the intensive group (mean 15.8 vs 17).
Intensive | Relaxed | ||
---|---|---|---|
Visual outcomes | Mean BCVA change from baseline to month 24 (letters) | 3.0 | 2.6 |
Proportion with 20/40 or better VA | 53.5% | 56.6% | |
Proportion with 20/200 or worse VA | 8.7% | 8.1% | |
Number of injections | 17.0 | 15.8 | |
Intervals | Porportion that did not extend beyond 4-week intervals | 13.5% | 2.8% |
Porportion that extended to and maintained 12-week | 15.0% | 29.6% |
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