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

April 6, 2021 updated by: Jae Hui Kim, Kim's Eye Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

512

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with treatment-naive active neovascular AMD and were treated with anti-VEGF

Description

Inclusion Criteria:

  • Patients diagnosed with treatment-naïve, active neovascular AMD between January 2017 and December 2017.
  • Patients aged ≥ 50 years old
  • Patients who received intravitreal anti-VEGF injection after the diagnosis

Exclusion Criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kim's Eye Hospital

Investigators

  • Principal Investigator: Jae Hui Kim, M.D., Kim's Eye Hospital, South Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 26, 2019

Primary Completion (ACTUAL)

January 26, 2020

Study Completion (ACTUAL)

July 26, 2020

Study Registration Dates

First Submitted

April 2, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (ACTUAL)

April 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-07-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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