An observational study in Age-related Macular Degeneration, sponsored by Kim's Eye Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Kim's Eye Hospital · Observational
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.
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.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's enrollment of 512 is above the median of 110 across 409 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Kim's Eye Hospital is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Patients diagnosed with treatment-naive active neovascular AMD and were treated with anti-VEGF
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Exclusion Criteria:
Intravitreal injection of either ranibizumab or aflibercept
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 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.
Time frame: Baseline
Plan to share: Undecided
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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