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

• ClinicalTrials.gov Identifier: NCT04836143
• Recruitment Status: Completed
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Sponsor: Kim's Eye Hospital
• Information provided by (Responsible Party): Jae Hui Kim, Kim's Eye Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Age-related Macular Degeneration	Drug: Intravitreal anti-vascular endothelial growth factor injection

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 Design

• Study Type: Observational
• Actual Enrollment: 512 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: 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
• Actual Study Start Date: August 26, 2019
• Actual Primary Completion Date: January 26, 2020
• Actual Study Completion Date: July 26, 2020

Groups and Cohorts

Intervention Details:

• Drug: Intravitreal anti-vascular endothelial growth factor injection
  Intravitreal injection of either ranibizumab or aflibercept

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Jae Hui Kim

Seoul, Korea, Republic of, 150-034

Sponsors and Collaborators

Kim's Eye Hospital

Investigators

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

More Information

Publications of Results:

Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17. Erratum in: Ophthalmology. 2013 Jan;120(1):209-10.

Moore TJ, Zhang H, Anderson G, Alexander GC. Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016. JAMA Intern Med. 2018 Nov 1;178(11):1451-1457. doi: 10.1001/jamainternmed.2018.3931.

Sertkaya A, Wong HH, Jessup A, Beleche T. Key cost drivers of pharmaceutical clinical trials in the United States. Clin Trials. 2016 Apr;13(2):117-26. doi: 10.1177/1740774515625964. Epub 2016 Feb 8.

Kim JH, Chang YS, Kim JW, Kim CG, Lee DW. Age-related differences in the prevalence of subtypes of Neovascular age-related macular degeneration in the first diagnosed eye. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):891-898. doi: 10.1007/s00417-018-04228-4. Epub 2019 Jan 7.

• Responsible Party: Jae Hui Kim, Consultant, Kim's Eye Hospital
• ClinicalTrials.gov Identifier: NCT04836143
• Other Study ID Numbers: 2019-07-015
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jae Hui Kim, Kim's Eye Hospital:

Age-related Macular Degeneration; Polypoidal Choroidal Vasculopathy

Additional relevant MeSH terms:

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Mitogens; Endothelial Growth Factors; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Growth Substances; Physiological Effects of Drugs