Age-related Macular DegenerationNCT04836143
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
An observational study of Age-related Macular Degeneration, run by Kim's Eye Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- Intravitreal anti-vascular endothelial growth factor injection
- Type of treatment
- Injection or infusion
- How many people
- 512 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Aug 2019to 26 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with treatment-naive active neovascular AMD and were treated with anti-VEGF
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Intravitreal anti-vascular endothelial growth factor injection
- Keywords
- Age-related Macular Degeneration, Polypoidal Choroidal Vasculopathy
- Medical subject headings
- Macular Degeneration, Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal anti-vascular endothelial growth factor injectionDrug
Intravitreal injection of either ranibizumab or aflibercept
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start26 Aug 2019
- Primary completion26 Jan 2020
- Study completion26 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kim's Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Hui Kim, Kim's Eye Hospital
- Investigators
- Jae Hui Kim, M.D., Principal investigator, Kim's Eye Hospital, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836143
- Sponsor's protocol ID
- 2019-07-015
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23084240Moore 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.
PubMed 30264133Sertkaya 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.
PubMed 26908540Kim 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.
PubMed 30617580
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04836143
- Acronym / sponsor ID
- 2019-07-015
- Conditions
- Age-related Macular Degeneration
- Keywords
- Age-related Macular Degeneration, Polypoidal Choroidal Vasculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Kim's Eye HospitalUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 26 Jan 2020 (actual)
- Study completion
- 26 Jul 2020 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with treatment-naive active neovascular AMD and were treated with anti-VEGF
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal anti-vascular endothelial growth factor injectionIntravitreal injection of either ranibizumab or aflibercept | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Results publication: PubMed 23084240Heier 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.
- Results publication: PubMed 30264133Moore 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.
- Results publication: PubMed 26908540Sertkaya 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.
- Results publication: PubMed 30617580Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Hui Kim, M.D. principal investigator
Kim's Eye Hospital, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Macular Degeneration, run by Kim's Eye Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836143, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.