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Clinical Trials Related to Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

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Choroidal Neovascularization

Abstracts

Well-designed prospective randomized controlled clinical trials of choroidal neovascularization secondary to age-related macular degeneration (CNV-AMD) have not only changed the gold standard of treatment but also changed the goal of treatment of CNV-AMD. Primary outcomes in those trials are demonstrated with strong statistical evidence that treatment with anti-vascular endothelial growth factor (anti-VEGF) agents can induce visual gain in lieu of preventing visual loss as in previous treatments.

All of the current widely used anti-VEGF agents, ranibizumab, bevacizumab, aflibercept, are not much different from each other in clinical applications for treatment of CNV-AMD. They can improve mean visual gain of treated patients in clinical trials between one line to two lines of visual acuity charts. For categorical visual acuity, the proportion of patients who gain more than three lines from the treatments is still less than 50%. It is approximately 30–40%. These outcomes can be translated into meaningful clinical use but with slightly less visual efficacy (mean visual gain of slightly less than one line of visual acuity chart with the proportion of gaining more than two lines approximately 35%).

Primary outcomes from many trials also suggested that monthly monitoring with as-needed treatments is not statistically inferior to the ideal monthly treatments; the treat and extend treatments may neither be statistically inferior to the as-needed treatments. The long-term visual outcomes after 2 years of anti-VEGF treatments, however, is still in doubt. There is no real safety concern of the treatments although there is neither strong statistical evidence to support.

Many clinical trials, or even some clinical managements, of CNV-AMD may be developed upon the secondary outcomes as well as post hoc analyses of randomized controlled trials. These outcomes should be interpreted with caution. Positive outcomes from these subgroup analyses may not be translated or carried over to the following larger clinical trials or to the real world.

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Abbreviations

ABC:

Avastin (bevacizumab) for choroidal neovascular age-related macular degeneration

ANCHOR:

Anti-VEGF antibody for the treatment of predominantly classic choroidal neovascularization in age-related macular degeneration

BRAMD:

Comparing the effectiveness of bevacizumab to ranibizumab in patients with exudative age-related macular degeneration

CATT:

The comparison of age-related macular degeneration treatments trials

DAWN:

Dorzolamide-timolol in combination with anti-vascular endothelial growth factor injections for wet age-related macular degeneration

DENALI:

Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration

EXCITE:

Efficacy and safety of monthly versus quarterly ranibizumab treatment in neovascular age-related macular degeneration

FOCUS:

RhuFab V2 ocular treatment combining the use of Visudyne to evaluate safety

GEFAL:

The Groupe d’Etude Français Avastin versus Lucentis dans la DMLA néovasculaire

HARBOR:

The pHase III, double-masked, multicenter, randomized, active treatment-controlled study of the efficacy and safety of 0.5 mg and 2.0 mg Ranibizumab administered monthly or on an as-needed basis (PRN) in patients with subfoveal neOvasculaR age-related macular degeneration

HAWK andHARRIER:

Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration

HORIZON:

Open-label extension trial of Ranibizumab for Choroidal neovascularization secondary to age-related macular degeneration

IVAN:

The inhibition of VEGF in age-related choroidal neovascularization trial

LUCAS:

The Lucentis compared to Avastin study

MANTA:

A randomised double-masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degeneration

MARINA:

Minimally classic/occult trial of the anti-VEGF antibody Ranibizumab in the treatment of Neovascular age-related macular degeneration

MONT BLANC:

Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration

PIER:

A phase IIIb, multicenter, randomized, double masked, sham injection controlled study of the efficacy and safety of Ranibizumab in subjects with Subfoveal Choroidal neovascularization [CNV] with or without classic CNV secondary to age-related macular degeneration

PrONTO:

Prospective optical coherence tomography (OCT) imaging of patients with Neovascular age-related macular degeneration (AMD) treated with intraOcular Ranibizumab

PROSPERO:

Conbercept for patients with age-related macular degeneration: a systematic review

REACH:

Evaluation of AGN-150998 in exudative age-related macular degeneration

RIVAL:

The comparison of Ranibizumab and Aflibercept for the development of geographic atrophy in (wet) AMD patients

SALUTE:

A randomized trial to compare the safety and efficacy of two ranibizumab dosing regimens in a Turkish cohort of patients with choroidal neovascularization secondary to AMD

SUSTAIN:

Safety and efficacy of a flexible dosing regimen of Ranibizumab in Neovascular age-related macular degeneration

TAP:

Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin

TREND:

TReat and extend study

TREX-AMD:

Treat-and-extend versus monthly dosing for Neovascular age-related macular degeneration

VIEW:

The VEGF trap-eye: Investigation of efficacy and safety in wet AMD

VIP:

Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration

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Authors and Affiliations

  1. Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand

    Paisan Ruamviboonsuk, Peranut Chotcomwonse, Variya Nganthavee & Warissara Pattanapongpaiboon

  2. Department of Ophthalmology, Faculty of Medicine, Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand

    Kornwipa Hemarat

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  4. Warissara Pattanapongpaiboon
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  1. Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA

    Jay Chhablani

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Ruamviboonsuk, P., Chotcomwonse, P., Nganthavee, V., Pattanapongpaiboon, W., Hemarat, K. (2020). Clinical Trials Related to Choroidal Neovascularization Secondary to Age-Related Macular Degeneration. In: Chhablani, J. (eds) Choroidal Neovascularization. Springer, Singapore. https://doi.org/10.1007/978-981-15-2213-0_20

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  • DOI: https://doi.org/10.1007/978-981-15-2213-0_20

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