A randomised controlled trial of alternative treatments to inhibit VEGF in age-related choroidal neovascularisation

Conditions

Age-related macular degeneration (AMD) Eye Diseases Age-related macular degeneration (AMD)

Peto T, Evans RN, Reeves BC, Harding S, Madhusudhan S, Lotery A, Downes S, Balaskas K, Bailey CC, Foss A, Ghanchi F, Yang Y, Phillips D, Rogers CA, Muldrew A, Hamill B, Chakravarthy U.

2022-03-1815 citations

10.1016/j.oret.2022.03.010

Effectiveness of Community versus Hospital Eye Service follow-up for patients with neovascular age-related macular degeneration with quiescent disease (ECHoES): a virtual non-inferiority trial

Barnaby C Reeves, Lauren J Scott, Jodi Taylor, Simon Harding, Tünde Pető et al. (12 authors)

BMJ Open2016-07-0117 citations

10.1136/bmjopen-2015-010685

Changes in intraocular pressure in study and fellow eyes in the IVAN trial

A. Foss, Lauren J Scott, Chris Rogers, Barnaby C Reeves, Faruque Ghanchi et al. (7 authors)

British Journal of Ophthalmology2016-04-1223 citations

10.1136/bjophthalmol-2015-307595

A randomised controlled trial to assess the clinical effectiveness and cost-effectiveness of alternative treatments to Inhibit VEGF in Age-related choroidal Neovascularisation (IVAN).

Chakravarthy U, Harding SP, Rogers CA, Downes S, Lotery AJ, Dakin HA, Culliford L, Scott LJ, Nash RL, Taylor J, Muldrew A, Sahni J, Wordsworth S, Raftery J, Peto T, Reeves BC.

2015-10-0175 citations

10.3310/hta19780

Cost-effectiveness of ranibizumab and bevacizumab for age-related macular degeneration: 2-year findings from the IVAN randomised trial

Helen Dakin, Sarah Wordsworth, Chris Rogers, Giselle Abangma, James Raftery et al. (11 authors)

BMJ Open2014-07-0178 citations

10.1136/bmjopen-2014-005094

Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial.

Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Culliford LA, Reeves BC, IVAN study investigators.

2013-07-19544 citations

10.1016/s0140-6736(13)61501-9

Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the IVAN randomized trial.

IVAN Study Investigators, Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Wordsworth S, Reeves BC.

2012-05-11572 citations

10.1016/j.ophtha.2012.04.015

Interventions

Participants, clinical staff and researchers will be masked to allocation of VEGF inhibition drug but not to stopping/continuing treatment at three months. Factor 1: Intravitreal inje

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults age =50 of either sex 2. Newly referred for the treatment of CNV caused by Age-related Macular Degeneration (AMD) in the first or second eye 3. Corrected 1 metre logarithmic minimal angle resolution visual acuity (VAlogMAR) =25 letters read on a standard Early Treatment Diabetic Retinopathy Study (ETDRS) chart 4. CNV involving the centre of the fovea If a fellow eye develops CNV from AMD, it will be treated with the optimal locally available treatment.

Exclusion criteria

Exclusion criteria: 1. Corrected 1 metre VAlogMAR <25 letters 2. Long standing CNV evidenced by the presence of fibrosis in excess of 50% of the total lesion 3. Presence of other active ocular disease causing concurrent vision loss, e.g. diabetic retinopathy 4. Previous treatment with PhotoDynamic Therapy (PDT) or a VEGF inhibitor in the eye being considered for inclusion

Design outcomes

Primary

Measure	Time frame
The primary outcome is corrected 1 metre VAlogMAR, measured as the number of letters read on a standard ETDRS chart. The primary end point will be VAlogMAR after two years of follow-up.	—

Secondary

Measure	Time frame
Secondary outcomes will be analysed after one and two years of follow-up, unless otherwise stated. 1. Frequencies of adverse effects of treatment 2. Generic and vision-specific health-related quality of life (HRQoL) 3. Treatment satisfaction 4. Cumulative resource use/cost, and cost-effectiveness 5. Clinical measures of vision 6. CNV morphology (from masked grading of fundus fluorescein angiograms [FFA] and optical coherence tomography scans [OCTs]). 7. Distance VAlogMAR after all patients have been followed for 1 year after starting treatment. 8. Survival free from treatment failure (i.e. satisfying one or more of the criteria for re-treatment).	—

Measure

Time frame

Secondary outcomes will be analysed after one and two years of follow-up, unless otherwise stated. 1. Frequencies of adverse effects of treatment 2. Generic and vision-specific health-related quality of life (HRQoL) 3. Treatment satisfaction 4. Cumulative resource use/cost, and cost-effectiveness 5. Clinical measures of vision 6. CNV morphology (from masked grading of fundus fluorescein angiograms [FFA] and optical coherence tomography scans [OCTs]). 7. Distance VAlogMAR after all patients have been followed for 1 year after starting treatment. 8. Survival free from treatment failure (i.e. satisfying one or more of the criteria for re-treatment).

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Countries

Northern Ireland, United Kingdom

Outcome results

None listed