June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Discontinuation and Loss to Follow-Up Rates in Clinical Trials of Intravitreal Anti-Vascular Endothelial Growth Factor Injections
Author Affiliations & Notes
  • Tatiana Rosenblatt
    Ophthalmology, Byers Eye Institute, Stanford University School of Medicine, California, United States
  • Nadim Rayess
    Ophthalmology, Byers Eye Institute, Stanford University School of Medicine, California, United States
  • Ahmad Al Moujahed
    Ophthalmology, Byers Eye Institute, Stanford University School of Medicine, California, United States
  • Prithvi Mruthyunjaya
    Ophthalmology, Byers Eye Institute, Stanford University School of Medicine, California, United States
  • Footnotes
    Commercial Relationships   Tatiana Rosenblatt, None; Nadim Rayess, None; Ahmad Al Moujahed, None; Prithvi Mruthyunjaya, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 169. doi:
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      Tatiana Rosenblatt, Nadim Rayess, Ahmad Al Moujahed, Prithvi Mruthyunjaya; Discontinuation and Loss to Follow-Up Rates in Clinical Trials of Intravitreal Anti-Vascular Endothelial Growth Factor Injections. Invest. Ophthalmol. Vis. Sci. 2021;62(8):169.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Clinical trials are often designed to include homogenous, highly specific patient populations with many resources to reduce patient dropout. Results may not translate to real-world settings. We performed a retrospective meta-epidemiological study to evaluate discontinuation and loss to follow-up (LTFU) rates in clinical trials of intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections for diabetic macular edema (DME), age-related macular degeneration (AMD), and retinal vein occlusion (RVO).

Methods : Clinicaltrials.gov was queried for all completed trials of anti-VEGF injections for DME, AMD, or RVO. Of the 658 trials identified, 582 were excluded for being non-interventional (n = 90), having fewer than 100 patients (n = 207), terminating early (n = 6), or missing study results (n = 279). The remaining 76 trials (DME n = 33, AMD n = 33, RVO n = 10) of 27,823 patients were analyzed for discontinuation and LTFU rates.

Results : Mean discontinuation rate was 12.44% (SD 8.12%, range 0 – 54.12%) (Figure 1A), with higher rates among control (18.87%) than treatment arms (10.78%, p = .006). Subject withdrawal was the most common reason for discontinuation, followed by adverse events and LTFU (Table 1). Mean LTFU rate was 1.84% (SD 1.78%, range 0 – 7.76%) (Figure 1B), with no significant differences when stratified by disease, treatment type, or treatment frequency.

Conclusions : Discontinuation rates of major intravitreal anti-VEGF clinical trials were highly variable, suggesting even trials struggle with overall patient retention. Though trial LTFU rates were low, real-world outcomes may differ due to higher reported LTFU rates, which should be considered when extrapolating trial results to clinical practice.

This is a 2021 ARVO Annual Meeting abstract.

 

Figure 1. Box and whiskers plots of median (middle line), 1st and 3rd interquartile ranges (ends of the boxes), and overall range (ends of whiskers with dotted outliers) for discontinuation (1A) and loss to follow-up (1B) rates among clinical trials of anti-VEGF injections for diabetic macular edema (DME), age-related macular degeneration (AMD), and retinal vein occlusion (RVO).

Figure 1. Box and whiskers plots of median (middle line), 1st and 3rd interquartile ranges (ends of the boxes), and overall range (ends of whiskers with dotted outliers) for discontinuation (1A) and loss to follow-up (1B) rates among clinical trials of anti-VEGF injections for diabetic macular edema (DME), age-related macular degeneration (AMD), and retinal vein occlusion (RVO).

 

Table 1. Discontinuation rates and reasons for discontinuation among clinical trials of anti-VEGF injections for diabetic macular edema (DME), age-related macular degeneration (AMD), and retinal vein occlusion (RVO).

Table 1. Discontinuation rates and reasons for discontinuation among clinical trials of anti-VEGF injections for diabetic macular edema (DME), age-related macular degeneration (AMD), and retinal vein occlusion (RVO).

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