NCT04836143

Eyes That Do Not Meet the Eligibility Criteria of Clinical Trials on Age-Related Macular Degeneration: Proportion of the Real-World Patient Population and Reasons for Exclusion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 512 (actual)
• Sponsor: Kim's Eye Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the present study was to evaluate the proportion of eyes that do not meet the eligibility criteria of clinical trials on neovascular AMD among the entire sample of eyes diagnosed with treatment-naïve neovascular AMD. The eligibility criteria of the VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) studies, were used for this investigation.

Detailed description

Neovascular AMD is one of the primary causes of severe visual impairment in developed countries. Previously, laser photocoagulation or photodynamic therapy was used as its mainstay treatment. However, the efficacy of these treatment modalities has obvious limitations. In 2006, the FDA-approved anti-VEGF agent, ranibizumab, was introduced, followed by aflibercept in 2012. In addition, the off-label use of bevacizumab has been widely adopted. The introduction of these anti-VEGF agents has markedly improved the treatment outcomes of neovascular AMD, resulting in a significant decrease in the rate of visual loss and blindness. Currently, clinical trials are actively being performed to develop better treatment methods for neovascular AMD. In general, conducting clinical trials are expensive and require years to complete. Therefore, estimating the time required to complete the planned patient enrollment is essential for establishing an efficient clinical trial plan. Clinical trials are usually conducted in a controlled environment and have sophisticated eligibility criteria. Thus, all patients cannot be enrolled into a trial, and some of them, or sometimes the majority of them, are excluded on the basis of the eligibility criteria. Estimation of the proportion of patients in the study population who do not meet the eligibility criteria is important for several reasons. First, it may help to identify whether the results of the clinical trial can be applied to the real-world patients. Secondly, it may also help to predict the time required to finish the planned patient enrollment. In addition, if a particular set of criteria results in the exclusion of a relatively large number of patients, patient enrollment in future clinical trials could be accelerated by modifying some of these criteria. Furthermore, since the characteristics of neovascular AMD differ between Asian and Caucasian populations, obtaining data on Asian populations would be of great value. Therefore, the purpose of the present study was to evaluate the proportion of eyes that do not meet the eligibility criteria of clinical trials on neovascular AMD among the entire sample of eyes diagnosed with treatment-naïve neovascular AMD. The eligibility criteria of the VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) studies, were used for this investigation.

Conditions

• Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Intravitreal anti-vascular endothelial growth factor injection	Intravitreal injection of either ranibizumab or aflibercept

Timeline

• Start date: 2019-08-26
• Primary completion: 2020-01-26
• Completion: 2020-07-26
• First posted: 2021-04-08
• Last updated: 2021-04-08

Locations

1 site across 1 country: South Korea