Retinal Vein OcclusionCAPTURENCT01875770
Continuing Assessment of Patients Treated With ranibizUmab for REtinal Vein Occlusion (CAPTURE)
An observational study of Retinal Vein Occlusion, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to assess the long term prognosis of patients treated with ranibizumab for edema due to retinal vein occlusion. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Retinal Vein Occlusion
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 3 Mar 2021
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who have been enrolled in the following three trials will be included in the study: A) "A Pilot, Open-Label Study of the Safety, Tolerability, and Bioactivity of Multiple Intravitreal Injections of Ranibizumab in Subjects with Macular Edema Secondary to Vein Occlusions.", B) "Extended follow-up of patients with macular edema due to bRanch rETinal vein occlusion (BRVO) or centrAl retinal veIn occlusioN (CRVO) previously treated with intravitreal ranibizumab (RETAIN) " C) "RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach (RELATE)"
Who may be able to join
- All patients who have been enrolled in the following three trials will be included in the study:
- "A Pilot, Open-Label Study of the Safety, Tolerability, and Bioactivity of Multiple Intravitreal Injections of Ranibizumab in Subjects with Macular Edema Secondary to Vein Occlusions.", B) "Extended follow-up of patients with macular edema due to bRanch rETinal vein occlusion (BRVO) or centrAl retinal veIn occlusioN (CRVO) previously treated with intravitreal ranibizumab (RETAIN) " C) "RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach (RELATE)"
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This research is being done to assess the long term prognosis of patients treated with ranibizumab for edema due to retinal vein occlusion.
Read the detailed description
People treated with ranibizumab for edema due to retinal vein occlusion as part of previous studies at the Wilmer Eye Institute and who are currently being seen by their ophthalmologist at the Wilmer Eye Institute are followed up to assess long term outcomes
- Conditions
- Retinal Vein Occlusion
- Keywords
- Retinal Vein Occlusion
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treated with Ranibizumab in previous trial | Treated with Ranibizumab in previous trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in BCVA at 5 and 10 years.
Mean change from baseline in BCVA at 5 and 10 years.
Measured: 10 years
Secondary outcomes (1)
Mean change from baseline in foveal thickness at 5 and 10 years
Mean change from baseline in foveal thickness at 5 and 10 years
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJan 2013
- Primary completion11 Oct 2018
- Study completion3 Mar 2021
Why it stopped: The study was terminated as patients could not be followed-up during the COVID pandemic. Since this was a non-intervention study, as per Johns Hopkins University policy, we had to hold off the patient visits during the pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Campochiaro, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875770
- Sponsor's protocol ID
- NA_00079952
- Acronym
- CAPTURE
- Status last verified
- May 2021
- First submitted
- 10 Jun 2013
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuing Assessment of Patients Treated With ranibizUmab for REtinal Vein Occlusion (CAPTURE)
- ClinicalTrials.gov ID
- NCT01875770
- Acronym / sponsor ID
- CAPTURE / NA_00079952
- Conditions
- Retinal Vein Occlusion
- Keywords
- Retinal Vein Occlusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated as patients could not be followed-up during the COVID pandemic. Since this was a non-intervention study, as per Johns Hopkins University policy, we had to hold off the patient visits during the pandemic.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 12 Jun 2013 (estimated)
- 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.
This research is being done to assess the long term prognosis of patients treated with ranibizumab for edema due to retinal vein occlusion.
Detailed description
People treated with ranibizumab for edema due to retinal vein occlusion as part of previous studies at the Wilmer Eye Institute and who are currently being seen by their ophthalmologist at the Wilmer Eye Institute are followed up to assess long term outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with Ranibizumab in previous trial | – | –Treated with Ranibizumab in previous trial |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have been enrolled in the following three trials will be included in the study: A) "A Pilot, Open-Label Study of the Safety, Tolerability, and Bioactivity of Multiple Intravitreal Injections of Ranibizumab in Subjects with Macular Edema Secondary to Vein Occlusions.", B) "Extended follow-up of patients with macular edema due to bRanch rETinal vein occlusion (BRVO) or centrAl retinal veIn occlusioN (CRVO) previously treated with intravitreal ranibizumab (RETAIN) " C) "RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach (RELATE)"
Key inclusion criteria (2 listed)
- All patients who have been enrolled in the following three trials will be included in the study:
- "A Pilot, Open-Label Study of the Safety, Tolerability, and Bioactivity of Multiple Intravitreal Injections of Ranibizumab in Subjects with Macular Edema Secondary to Vein Occlusions.", B) "Extended follow-up of patients with macular edema due to bRanch rETinal vein occlusion (BRVO) or centrAl retinal veIn occlusioN (CRVO) previously treated with intravitreal ranibizumab (RETAIN) " C) "RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach (RELATE)"
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.
Primary outcome
Mean change from baseline in BCVA at 5 and 10 years.
Time frame: 10 years
Mean change from baseline in BCVA at 5 and 10 years.
1 secondary outcome
Mean change from baseline in foveal thickness at 5 and 10 years
Time frame: 10 years
Results and safety
The study was stopped early (reason given: The study was terminated as patients could not be followed-up during the COVID pandemic. Since this was a non-intervention study, as per Johns Hopkins University policy, we had to hold off the patient visits during the pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
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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.
Peter Campochiaro, MD principal investigator
Johns Hopkins University
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 Retinal Vein Occlusion, run by Johns Hopkins University at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 12 Oct 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 United States. 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 was stopped early (reason given: The study was terminated as patients could not be followed-up during the COVID pandemic. Since this was a non-intervention study, as per Johns Hopkins University policy, we had to hold off the patient visits during the pandemic.). Results are not available in the source record.
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?
Mean change from baseline in BCVA at 5 and 10 years. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2021.