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A Systematic Review of the Treat and Extend Treatment Regimen with Anti-VEGF Agents for Neovascular Age-Related Macular Degeneration.

ABSTRACT: Despite significant progress in retaining vision for neovascular age-related macular degeneration patients in the era of treatment with intravitreal anti-VEGF agents, there is no universally accepted treatment regimen that defines the frequency of treatment needed to achieve the optimal visual outcomes while simultaneously balancing the burden of long-term, frequent and high-cost treatment. Treat and extend has recently and consistently been used by retina specialists to minimise the financial and psychological costs of the need for frequent treatment with anti-VEGF injections. This is a systematic review that presents evidence from clinical trials and the real world on the utilisation of treat and extend with anti-VEGF intravitreal injections in neovascular age-related macular degeneration, and discusses the experience gained thus far from the utilisation of such regimens to preserve vision when treating patients over the long-term.

SUBMITTER: Gemenetzi M

PROVIDER: S-EPMC5449306 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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A Systematic Review of the Treat and Extend Treatment Regimen with Anti-VEGF Agents for Neovascular Age-Related Macular Degeneration.

Gemenetzi Maria M Patel Praveen J PJ

Ophthalmology and therapy 20170427 1

Despite significant progress in retaining vision for neovascular age-related macular degeneration patients in the era of treatment with intravitreal anti-VEGF agents, there is no universally accepted treatment regimen that defines the frequency of treatment needed to achieve the optimal visual outcomes while simultaneously balancing the burden of long-term, frequent and high-cost treatment. Treat and extend has recently and consistently been used by retina specialists to minimise the financial a ...[more]

PMID: 28451952

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Project description:PurposeTo compare the efficacy and safety of conbercept using a treat-and-extend (T&E) regimen vs. a pro re nata (PRN) regimen in Chinese patients with neovascular age-related macular degeneration (nAMD).MethodsThis was a randomized, multicenter, non-inferiority study. After an initial loading phase of three consecutive monthly intravitreal injections of 0.5 mg Conbercept, the patients were treated to PRN or T&E regimen. The prespecified retreatment criteria was defined as a more than 5-letter decrease in BCVA from the previous visit or any evidence of new retinal hemorrhages, or the presence of any IRF and any SRF of more than 200 μm in height at the sub-foveal center. The primary outcome was the mean change in best-corrected visual acuity (BCVA) from baseline to 24 months, with a prespecified non-inferiority limit of -5 letters.ResultsFrom July 2016 through August 2018, 141 participants were allocated and treated (T&E, n = 69; PRN, n = 72). About one fifth of the overall participants were dropped out during the 12-month follow-up (28/141, 19.9%), and about one thirds of the overall participants were lost during the 24-month follow-up (51/141, 36%). At 2 years, mean BCVA letter improvement was + 4.0 in the T&E group vs. + 5.1 in the PRN group, and T&E regimen was not non-inferior to PRN regimen [difference, -1.169 letters; 95% confidence interval (CI): -6.864 ∼ 4.526]. Subgroup analyses also demonstrate the similar results in PCV patients, naive patients and no-naive patients. The mean decrease in central subfield thickness were 180 ± 165 μm in the T&E group and 247 ± 230 μm in the PRN group, respectively. The patients in the PRN group had required significantly fewer injections than those in the T&E group (12.4 vs. 14.6 injections, P = 0.041). The types and rates of adverse events were comparable in the two treatment groups.ConclusionThese findings suggest that the T&E regimen was not non-inferior to the PRN regimen in patients with nAMD in terms of BCVA outcomes through 24 months.Clinical trial registrationClinicalTrials.gov, identifier NCT02802657.

Project description:PurposeTo probabilistically forecast needed anti-vascular endothelial growth factor (anti-VEGF) treatment frequency using volumetric spectral domain-optical coherence tomography (SD-OCT) biomarkers in neovascular age-related macular degeneration from real-world settings.MethodsSD-OCT volume scans were segmented with a custom deep-learning-based analysis pipeline. Retinal thickness and reflectivity values were extracted for the central and the four inner Early Treatment Diabetic Retinopathy Study (ETDRS) subfields for six retinal layers (inner retina, outer nuclear layer, inner segments [IS], outer segments [OS], retinal pigment epithelium-drusen complex [RPEDC] and the choroid). Machine-learning models were probed to predict the anti-VEGF treatment frequency within the next 12 months. Probabilistic forecasting was performed using natural gradient boosting (NGBoost), which outputs a full probability distribution. The mean absolute error (MAE) between the predicted versus actual anti-VEGF treatment frequency was the primary outcome measure.ResultsIn a total of 138 visits of 99 eyes with neovascular AMD (96 patients) from two clinical centers, the prediction of future anti-VEGF treatment frequency was observed with an accuracy (MAE [95% confidence interval]) of 2.60 injections/year [2.25-2.96] (R2 = 0.390) using random forest regression and 2.66 injections/year [2.31-3.01] (R2 = 0.094) using NGBoost, respectively. Prediction intervals were well calibrated and reflected the true uncertainty of NGBoost-based predictions. Standard deviation of RPEDC-thickness in the central ETDRS-subfield constituted an important predictor across models.ConclusionsThe proposed, fully automated pipeline enables probabilistic forecasting of future anti-VEGF treatment frequency in real-world settings.Translational relevancePrediction of a probability distribution allows the physician to inspect the underlying uncertainty. Predictive uncertainty estimates are essential to highlight cases where human-inspection and/or reversion to a fallback alternative is warranted.

Project description:Background/purposeTreating neovascular age-related macular degeneration with intravitreal aflibercept treat-and-extend (T&E) can reduce treatment burden. ARIES assessed whether intravitreal aflibercept early-start T&E was noninferior to late-start T&E.MethodsA randomized, open-label, Phase 3b/4 study that included treatment-naïve patients aged ≥50 years with the best-corrected visual acuity 73-25 Early Treatment Diabetic Retinopathy Study letters and active choroidal neovascularization secondary to AMD. Patients received 2 mg intravitreal aflibercept at Week (W) 0, W4, W8, and W16. At W16, patients were randomized 1:1 to early-start (2W interval adjustments) or late-start T&E (8W intervals until W48 then 2W interval adjustments). Primary endpoint: the best-corrected visual acuity change from randomization to W104.ResultsTwo-hundred seventy-one patients were randomized. The mean (SD) best-corrected visual acuity at baseline was 60.2 (12.1; early-T&E) and 61.3 (10.8; late-T&E) letters. The mean (SD) best-corrected visual acuity change (W16-104) was -2.1 (11.4) versus -0.4 (8.4) letters (early-T&E vs. late-T&E; least-squares mean difference: -2.0; 95% confidence interval: -4.75 to 0.71; P = 0.0162 for noninferior); +4.3 (13.4) versus +7.9 (11.9) letters (W0-104). The mean (SD) number of injections was 12.0 (2.3) versus 13.0 (1.8). From baseline to W104, 93.4% and 96.2% maintained best-corrected visual acuity; the mean (SD) central retinal thickness change was -161.6 (135.6) µm and -158.6 (125.1) µm. The last injection interval (W104) was ≥12W for 47.2% and 51.9% of patients.ConclusionOutcomes were similar between patients with neovascular age-related macular degeneration treated with an intravitreal aflibercept early-T&E or late-T&E regimen after initial dosing, with one injection difference over 2 years.Trial registrationClinicalTrials.gov Identifier: NCT02581891 https://clinicaltrials.gov/ct2/show/NCT02581891. Supplemental Digital Contents (files 1 http://links.lww.com/IAE/B419).

Dataset Information

A Systematic Review of the Treat and Extend Treatment Regimen with Anti-VEGF Agents for Neovascular Age-Related Macular Degeneration.

Publications

A Systematic Review of the Treat and Extend Treatment Regimen with Anti-VEGF Agents for Neovascular Age-Related Macular Degeneration.

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