Randomized Phase IIb Study of Brimonidine Drug Delivery System Generation 2 for Geographic Atrophy in Age-Related Macular Degeneration

Bandello, Francesco; Kim, Kimmie; López, Francisco J.; Chen, Fred K.; Guymer, Robyn H.; Korobelnik, Jean‐François; Souied, Eric H.; Holz, Frank G.; Ziemssen, Focke; Bandello, Francesco; Campos, Emilio C.; Grignolo/Eandi, Chiara; Midena, Edoardo; Peiretti, Enrico; Staurenghi, Giovanni; Viola, Francesco; Bailey, Clare; Esposti, Simona Degli; Jackson, Timothy L.; Menon, Geeta; Pagliarini, Sergio; Quhill, Fahd; Antoszyk, Andrew N.; Brooks, Logan; Callanan, David; Csaky, Karl G.; Edwards, Albert O.; Eichenbaum, David; Freeman, William R.; Ghuman, Avtar Thomas; González, Víctor H.; Gupta, Sunil; Hamilton, Richard; Khurana, Rahul N.; Kunimoto, Derek; Kuppermann, Baruch D.; Lauer, Andreas K.; Lee, Seong-Young; Maturi, Raj K.; Patel, Sunil; Reddy, Rahul; Rich, Ryan; Rivellese, Mark; Rose, Steven; Segal, Zachary; Wong, Robert

doi:10.1016/j.oret.2023.03.001

Cited by 7 publications

(6 citation statements)

References 33 publications

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“…Secondary analysis showed that the effect on GA growth increased by 71% in the population with lesion sizes >4.5 mm 2 . Within the entire population, there was a trend of reduction by 9% ( P = 0.070) and 9% ( P = 0.066) at 24 and 30 months, respectively 17 . The study was stopped at interim analysis because of slow GA lesion progression rate (∼1.6 mm 2 ) in the enrolled population.…”

Section: Emerging Nonexudative Amd Treatmentsmentioning

confidence: 99%

“…The primary outcome was the change from baseline in GA lesion area at month 24. There was a 10% and 12% reduction of GA area growth in the treatment groups at months 24 and 30, respectively 17 . The secondary outcomes included mean changes in the best-corrected visual acuity (BCVA) and low luminance visual acuity (LLVA).…”

Section: Emerging Nonexudative Amd Treatmentsmentioning

confidence: 99%

“…There was a 10% and 12% reduction of GA area growth in the treatment groups at months 24 and 30, respectively. 17 The secondary outcomes included mean changes in the best-corrected visual acuity (BCVA) and low luminance visual acuity (LLVA). There was no difference in BCVA (P ¼ 0.390; least squares mean difference CI -3.9 to 1.5) or LLVA (P ¼ 0.301; least squares mean difference CI -4.2 to 1.3) between the 2 arms at month 24.…”

Section: Brimonidine Ddsmentioning

confidence: 99%

“…Within the entire population, there was a trend of reduction by 9% (P ¼ 0.070) and 9% (P ¼ 0.066) at 24 and 30 months, respectively. 17 The study was stopped at interim analysis because of slow GA lesion progression rate ($1.6 mm 2 ) in the enrolled population. Two phase 3, randomized, prospective, multicentered studies of 200 and 400 mcg of the Brimonidine DDS (IMAGINE and ENVI-SION) are planned.…”

Section: Brimonidine Ddsmentioning

confidence: 99%

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Emerging Therapies in Nonexudative Age-Related Macular Degeneration in 2020

Samanta¹,

Aziz

Jhingan

et al. 2021

Asia-Pacific Journal of Ophthalmology

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Age-related macular degeneration (AMD) is one of the most common causes of severe vision loss in the developed world. Advanced forms of AMD are seen in primarily 2 types, exudative AMD involving the presence of choroidal neovascularization and nonexudative or dry AMD with geographic atrophy. For the latter, the combination of vitamins and minerals known as the Age-Related Eye Disease Study-2 formulation has been shown to decrease the rate of progression of nonexudative to exudative AMD, as no other treatments are currently approved for nonexudative AMD. This review will highlight upcoming treatments for nonexudative AMD. Six upcoming agents have shown results at least in the 2A phase. This includes intravitreal agents that are inhibitors of integrin (Risuteganib), intravitreal agents that disrupt the complement pathway (Zimura, APL-2), neuroprotective implants (Brimonidine DDS), a subcutaneous injectable (Elamipretide), and photobiomodulation (Valeda Light Delivery System).

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Section: Emerging Nonexudative Amd Treatmentsmentioning

confidence: 99%

Section: Emerging Nonexudative Amd Treatmentsmentioning

confidence: 99%

Section: Brimonidine Ddsmentioning

confidence: 99%

Section: Brimonidine Ddsmentioning

confidence: 99%

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Emerging Therapies in Nonexudative Age-Related Macular Degeneration in 2020

Samanta¹,

Aziz

Jhingan

et al. 2021

Asia-Pacific Journal of Ophthalmology

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“…In summary, a structured questionnaire was used to quantify participants’ attitudes to acceptability, as well as open-ended questions to explore participants’ beliefs, hopes and concerns regarding GA treatment within their unique contexts and circumstances. Information communicated to participants about the treatments’ efficacy was based on Phase 2 clinical trial results [ 21 – 23 ].…”

Section: Methodsmentioning

confidence: 99%

Exploring patient acceptability of emerging intravitreal therapies for geographic atrophy: A mixed-methods study

Enoch

Ghulakhszian

Sekhon

et al. 2023

Eye

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Background/Objectives The acceptability of emerging intravitreal therapies for patients with Geographic Atrophy (GA) is currently unknown. This study therefore aimed to investigate the extent to which regular intravitreal injections may be acceptable to GA patients. Subjects/Methods Thirty UK-based individuals with GA secondary to age-related macular degeneration (AMD), recruited from two London-based hospitals, were interviewed in April-October 2021 regarding acceptability of new GA treatments. Participants responded to a structured questionnaire, as well as open-ended questions in a semi-structured interview. The Theoretical Framework of Acceptability (TFA) informed framework analysis of the qualitative data. Results Twenty participants (67%) were female, and median (interquartile range (IQR)) age was 83 (78, 87) years. 37% of participants had foveal centre-involving GA, and better eye median (IQR) logMAR visual acuity was 0.30 (0.17, 0.58). Data suggested that 18 participants (60% (95% CI: 41–79%)) would accept the treatment, despite awareness of potential drawbacks. Eight participants (27% (95% CI: 10–43%) were ambivalent or undecided about treatment, and four (13%) (95% CI: 0–26%) would be unlikely to accept treatment. Reducing the frequency of injections from monthly to every other month increased the proportion of participants who considered the treatments acceptable. Conversely, factors limiting acceptability clustered around: the limited magnitude of treatment efficacy; concerns about side effects or the increased risk of neovascular AMD; and the logistical burden of regular clinic visits for intravitreal injections. Misunderstandings of potential benefits indicate the need for appropriately-designed patient education tools to support decision-making. Conclusions Our study suggests a majority of participants would be positive about intravitreal treatment for GA, in spite of potential burdens.

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