IVAN cohort extension study

Five year observational follow-up of the IVAN trial cohort: a study of function and morphology - IVAN Follow Up

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002608-97-GB

Enrollment

610

Registered

2015-09-08

Start date

2015-09-09

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular age-related macular degeneration MedDRA version: 18.1 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: Avastin Product Name: NA Product Code: NA Pharmaceutical Form: Solution for injection INN or Proposed INN: bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: i) Participated in the original IVAN trial. For attended visits and the postal questionnaire: ii) Able to give informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 610

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: This will be at one timepoint on average 5 years since enrollment in the IVAN trial.;Main Objective: To investigate the care of IVAN participants in the NHS, and changes to their vision, since the end of the IVAN trial in order to better inform future NHS strategies for treatment of wet Age-related Macular Degeneration.; Secondary Objective: Geographic Atrophy (GA) is a physical change that happens in the back of the eye. It can be measured and graded. Images taken in the original IVAN study, on average between 3 and 5 years ago, can be compared against images taken during this study. From that comparison we can; • Describe how many of the IVAN participants have developed Geographic Atrophy. • Describe the rate of change in those participants who already had Geographic Atrophy. • Estimate if there was any link or effect between the Geographic Atrophy severity and the the trial allocations, the numbers of treatments administered during the trial, the participants’ management and clinical outcomes and health status (as measured using questionnaires). • To estimate the effects of original trial allocations on the rate of development of new Geographic Atrophy. • To investigate whether new Geographic Atrophy has a long term impact on visual function and health status (as measured using questionnaires), which could poten ;Primary end point(s): The primary outcome will be the development of new atrophy. This outcome will be determined from colour fundus (CF), OCT and autofluorescence images (where available) of the study eye. The images are submitted to the Network of Ophthalmic Reading Centres (NetwORC). NetwORC will grade all images that are submitted without knowledge of experimental allocations or other exposures of interest and classify study eyes as having developed new atrophy or not.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: This will be at one timepoint on average 5 years since enrollment in the IVAN trial.;Main Objective: To investigate the care of IVAN participants in the NHS, and changes to their vision, since the end of the IVAN trial in order to better inform future NHS strategies for treatment of wet Age-related Macular Degeneration.; Secondary Objective: Geographic Atrophy (GA) is a physical change that happens in the back of the eye. It can be measured and graded. Images taken in the original IVAN study, on average between 3 and 5 years ago, can be compared against images taken during this study. From that comparison we can; • Describe how many of the IVAN participants have developed Geographic Atrophy. • Describe the rate of change in those participants who already had Geographic Atrophy. • Estimate if there was any link or effect between the Geographic Atrophy severity and the the trial allocations, the numbers of treatments administered during the trial, the participants’ management and clinical outcomes and health status (as measured using questionnaires). • To estimate the effects of original trial allocations on the rate of development of new Geographic Atrophy. • To investigate whether new Geographic Atrophy has a long term impact on visual function and health status (as measured using questionnaires), which could poten ;Primary end point(s): The primary outcome will be the development of new atrophy. This outcome will be determined from colour fundus (CF), OCT and autofluorescence images (where available) of the study eye. The images are submitted to the Network of Ophthalmic Reading Centres (NetwORC). NetwORC will grade all images that are submitted without knowledge of experimental allocations or other exposures of interest and classify study eyes as having developed new atrophy or not.

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Secondary

Measure	Time frame
Secondary end point(s): • Best corrected distance visual acuity (BCVA; VAlogMAR), with standard and low luminance, using the standard ETDRS Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. This will be recorded for each visit from a participant’s medical record for both study and fellow eyes. • Duration of monitoring for reactivation: This will be derived from the date of first treatment in the IVAN trial and the date of the last / most recent monitoring visit documented in the medical records. If a participant has been discharged at some point since exiting the IVAN trial, then restarted treatment, the date of restarting treatment (and subsequent cessation of monitoring) will be recorded. If a fellow eye has developed nAMD requiring treatment during or after exiting the IVAN trial, the same information will be recorded for the fellow eye. • Number of visits: In addition, the eye(s) being monitored at each visit will be recorded, i.e. study, fellow or both. • Number of injections: This outcome will be recorded separately for study and fellow eyes. The drug used for each treatment will also be recorded • nAMD status of fellow eye • EuroQol EQ-5D-5L ;Timepoint(s) of evaluation of this end point: as per primary endpoint	—

Measure

Time frame

Secondary end point(s): • Best corrected distance visual acuity (BCVA; VAlogMAR), with standard and low luminance, using the standard ETDRS Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. This will be recorded for each visit from a participant’s medical record for both study and fellow eyes. • Duration of monitoring for reactivation: This will be derived from the date of first treatment in the IVAN trial and the date of the last / most recent monitoring visit documented in the medical records. If a participant has been discharged at some point since exiting the IVAN trial, then restarted treatment, the date of restarting treatment (and subsequent cessation of monitoring) will be recorded. If a fellow eye has developed nAMD requiring treatment during or after exiting the IVAN trial, the same information will be recorded for the fellow eye. • Number of visits: In addition, the eye(s) being monitored at each visit will be recorded, i.e. study, fellow or both. • Number of injections: This outcome will be recorded separately for study and fellow eyes. The drug used for each treatment will also be recorded • nAMD status of fellow eye • EuroQol EQ-5D-5L ;Timepoint(s) of evaluation of this end point: as per primary endpoint

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Countries

United Kingdom

Contacts

Public ContactUsha Chakravarthy

Belfast Health and Social Care Trust

u.chakravarthy@qub.ac.uk02890632527

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026