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

NCT04836143 | Completed DMC

• 1 other identifier: 2019-07-015
• Study Type: observational
• Target: 512
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Macular Degeneration

Keywords

Age-related Macular Degeneration; Polypoidal Choroidal Vasculopathy

Outcome Measures

Primary Outcomes (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

  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

Interventions

Intravitreal anti-vascular endothelial growth factor injection DRUG

Intravitreal injection of either ranibizumab or aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Kim's Eye Hospital: lead

Study Sites (1)

Jae Hui Kim

Seoul, 150-034, South Korea

Location

Related Publications (4)

• 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.

  PMID: 23084240 RESULT

• 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.

  PMID: 30264133 RESULT

• 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.

  PMID: 26908540 RESULT

• 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.

  PMID: 30617580 RESULT

MeSH Terms

Conditions

Macular Degeneration; Polypoidal Choroidal Vasculopathy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jae Hui Kim, M.D.

  Kim's Eye Hospital, South Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 8, 2021
• Study Start: August 26, 2019
• Primary Completion: January 26, 2020
• Study Completion: July 26, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

KR (1)