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Retina October 2024

Endpoints and Design for Clinical Trials in USH2A -Related Retinal Degeneration: Results and Recommendations From the RUSH2A Natural History Study

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Maureen G. Maguire; David G. Birch; Jacque L. Duncan; Allison R. Ayala; Lauren N. Ayton; Janet K. Cheetham; Peiyao Cheng; Todd A. Durham; Frederick L. Ferris, III; Carel B. Hoyng; Rachel M. Huckfeldt; Glenn J. Jaffe; Christine Kay; Eleonora M. Lad; Bart P. Leroy; Wendi Liang; Lee S. McDaniel; Michele Melia; Michel Michaelides; Mark E. Pennesi; José-Alain Sahel; Lassana Samarakoon; on behalf of the REDI Working Group and the Foundation Fighting Blindness Clinical Consortium Investigator Group
TAGS: cohort studies, eye, natural history, outcome measures, retinal degeneration, sample size, surrogate endpoints, vision, united states food and drug administration, perimetry
Trans. Vis. Sci. Tech.. 2024; 13(10):15. https://doi.org/10.1167/tvst.13.10.15

Includes: Supplemental Content

ARVO Annual Meeting Abstract June 2024

Gildeuretinol Enables the Vitamin A Cycle

Hendrik P Scholl; Leonide Saad; Gabrielle DeBartolomeo; Neil M Bressler; Stephen H Tsang; Kimberly E Stepien; Paul S Bernstein; Byron L Lam; Michael B Gorin; Ilyas Washington; Christine Nichols Kay

Invest. Ophthalmol. Vis. Sci.. 2024; 65(7):6438.

ARVO Annual Meeting Abstract June 2024

Gildeuretinol Arrested Stargardt Disease, The TEASE-3 Study

Michael B Gorin; Leonide Saad; Gabrielle DeBartolomeo; Ilyas Washington; Hendrik P Scholl; Marc T. Mathias; Philip Ferrone; Christine Nichols Kay

Invest. Ophthalmol. Vis. Sci.. 2024; 65(7):3310.

ARVO Annual Meeting Abstract June 2024

Longitudinal imaging of the parafoveal cone mosaic in congenital achromatopsia

Nickolas Chen; Katie M Litts; Danica Nikezic; Christopher S Langlo; Brian P Higgins; Byron L Lam; Fred Collison; Mark E Pennesi; Christine Nichols Kay; Sergey Tarima; Joseph Carroll

Invest. Ophthalmol. Vis. Sci.. 2024; 65(7):1428.

ARVO Annual Meeting Abstract June 2024

Photoreceptor structure following gene therapy in CNGA3 -mediated Achromatopsia: adaptive optics imaging results from a Phase 1/2 dose escalation clinical trial for AGTC-402 (rAAV2tYF-PR1.7-hCNGA3)

Yu You Jiang; Peiluo Xu; Christine Nichols Kay; Robert Sisk; Rachel M Huckfeldt; Jason Comander; Byron L Lam; Ninel Z. Gregori; Audina Berrocal; Mark E Pennesi; Andreas K Lauer; Amy Christenson; Nadia K Waheed; Jessica Ijams Wolfing Morgan

Invest. Ophthalmol. Vis. Sci.. 2024; 65(7):3289.

Perspective June 2023

Overcoming the Challenges to Clinical Development of X-Linked Retinitis Pigmentosa Therapies: Proceedings of an Expert Panel

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David G. Birch; Janet K. Cheetham; Stephen P. Daiger; Carel Hoyng; Christine Kay; Ian M. MacDonald; Mark E. Pennesi; Lori S. Sullivan
TAGS: gene therapy, mutation, natural history, phenotype, retinitis pigmentosa, x-linked inheritance, disease progression, blindness, retinal diseases, surrogate endpoints
Trans. Vis. Sci. Tech.. 2023; 12(6):5. https://doi.org/10.1167/tvst.12.6.5

ARVO Annual Meeting Abstract June 2023

Interim results for the Phase 1/2 PRISM Trial evaluating 4D-150, a dual-transgene intravitreal genetic medicine in individuals with neovascular (wet) age-related macular degeneration

Arshad M. Khanani; Vrinda S Hershberger; Christine Nichols Kay; Allen Hu; David Aaron Eichenbaum; Glenn J Jaffe; Carol Chung; Somayeh Honarmand; Chyong Nien; Schonmei Lee; Harsha Kabra; David Kirn; Robert Kim

Invest. Ophthalmol. Vis. Sci.. 2023; 64(8):5055.

ARVO Annual Meeting Abstract June 2023

Six-month safety and efficacy of ATSN-101 in patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1)

Christine Nichols Kay; Paul Yang; Artur V Cideciyan; Allen Ho; Andreas K Lauer; Shannon E Boye; Sanford L Boye; Alejandro J Roman; Vivian Wu; Alexandra V Garafalo; Alexander Sumaroka; Laura P Pardon; Dan Yoon; Kenji P Fujita; Samuel Jacobson

Invest. Ophthalmol. Vis. Sci.. 2023; 64(8):1914.

ARVO Annual Meeting Abstract June 2022

Psychometric validation of patient-reported outcome (PRO) and observer-reported outcome (ObsRO) measures in Retinitis Pigmentosa and Leber Congenital Amaurosis

Isabelle S Audo; Nicola Williamson; Melissa Barclay; Joel Sims; Kieran Boparai; Francesco Patalano; Christel Naujoks; Claudio Spera; Judit Banhazi; Paul O’Brien; Christine Kay; Jane Green; Todd Durham; Helena Bradley; M Dominik Fischer

Invest. Ophthalmol. Vis. Sci.. 2022; 63(7):2663.

ARVO Annual Meeting Abstract June 2022

Findings on visual photosensitivity in two phase 1/2 clinical trials of subretinal gene therapy with AGTC-401 and AGTC-402 for CNGB3 and CNGA3 achromatopsia

Rachel M Huckfeldt; Jason Comander; Mark E Pennesi; Paul Yang; Andreas Lauer; Robert Sisk; Edward Averbukh; Eyal Banin; Ninel Z Gregori; Janet L Davis; Byron L Lam; Christine Nichols Kay; Jessica Ijams Wolfing Morgan; Joseph Carroll; Bright Senyo Ashimatey; Matthew Feinsod

Invest. Ophthalmol. Vis. Sci.. 2022; 63(7):450.

ARVO Annual Meeting Abstract June 2022

Generation of qualitative evidence to support the content validity of the ViSIO-PRO and ViSIO-ObsRO in Retinitis Pigmentosa and Leber Congenital Amaurosis

Christine Nichols Kay; Isabelle S Audo; Helena Bradley; Melissa Barclay; Joel Sims; Kieran Boparai; Francesco Patalano; Christel Naujoks; Claudio Spera; Daniel Viriato; M Dominik Fischer; Jane Green; Todd Durham; Nicola Williamson; Judit Banhazi

Invest. Ophthalmol. Vis. Sci.. 2022; 63(7):1711 – F0029.

ARVO Annual Meeting Abstract June 2022

Interim Safety Results in Two Phase 1/2 Open-label, Dose-escalation Clinical Trials of Subretinal Gene Therapy with AGTC-401 (rAAV2tYF-PR1.7-hCNGB3) and AGTC-402 (rAAV2tYF-PR1.7-hCNGA3) in Subjects with Achromatopsia (ACHM)

Alessandro Iannaccone; Mark E Pennesi; Paul Yang; Andreas Lauer; Robert Sisk; Ninel Z Gregori; Janet L Davis; Byron L Lam; Christine Nichols Kay; Mauro Goldbaum; Bright Senyo Ashimatey; Feng Zhu; Matthew Feinsod; Lejla Vajzovic

Invest. Ophthalmol. Vis. Sci.. 2022; 63(7):2829 – A0345.

ARVO Annual Meeting Abstract June 2021

Qualitative interviews with patients and caregivers regarding visual function impairments and impacts on vision-dependent activities of daily living and health-related quality of life in RPE65-related Retinitis Pigmentosa and Leber Congenital Amaurosis

Christine Kay; Nicola Williamson; Helena Bradley; Melissa Barclay; Joel Sims; Rob Arbuckle; Claudio Spera; Christel Naujoks; Nuzhat Afroz; M Dominik Fischer; Isabelle Audo; Todd Durham; Francesco Patalano; Judit Banhazi

Invest. Ophthalmol. Vis. Sci.. 2021; 62(8):3589.

ARVO Annual Meeting Abstract June 2021

Twelve-month Findings from Two Phase 1/2 Clinical Studies of Subretinal Gene Therapy Drugs for Achromatopsia

Mark E Pennesi; Paul Yang; Andreas Lauer; Robert A Sisk; Jason M Comander; Rachel M. Huckfeldt; Edward Averbuhk; Eyal Banin; Ninel Gregori; Janet L Davis; Byron L Lam; Christine Kay; Erin Leone; Deanine Halliman; Nnenna Ihekoromadu; Matthew Feinsod

Invest. Ophthalmol. Vis. Sci.. 2021; 62(8):3321.

ARVO Annual Meeting Abstract June 2021

Visual function improvements with BIIB112 (NSR-RPGR) in X-linked retinitis pigmentosa: XIRIUS (dose-expansion) and XOLARIS (natural disease progression) studies

Robert E MacLaren; Byron L Lam; Andrew J Lotery; Paulo Eduardo Stanga; Assad Jalil; Mark E Pennesi; David G Birch; Christine Kay; Jiajun Liu; Eileen Liao; Lenore von Krusenstiern

Invest. Ophthalmol. Vis. Sci.. 2021; 62(8):1479.

Articles May 2021

Examining Whether AOSLO-Based Foveal Cone Metrics in Achromatopsia and Albinism Are Representative of Foveal Cone Structure

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Katie M. Litts; Erica N. Woertz; Niamh Wynne; Brian P. Brooks; Alicia Chacon; Thomas B. Connor, Jr.; Deborah Costakos; Alina Dumitrescu; Arlene V. Drack; Gerald A. Fishman; William W. Hauswirth; Christine N. Kay; Byron L. Lam; Michel Michaelides; Mark E. Pennesi; Kimberly E. Stepien; Sasha Strul; C. Gail Summers; Joseph Carroll
TAGS: achromatopsia, albinism, retinal cone, diagnostic imaging, mosaicism
Trans. Vis. Sci. Tech.. 2021; 10(6):22. https://doi.org/10.1167/tvst.10.6.22

Includes: Supplemental Content

Articles January 2021

Optical Coherence Tomography Artifacts Are Associated With Adaptive Optics Scanning Light Ophthalmoscopy Success in Achromatopsia

PDF

Katie M. Litts; Erica N. Woertz; Michalis Georgiou; Emily J. Patterson; Byron L. Lam; Gerald A. Fishman; Mark E. Pennesi; Christine N. Kay; William W. Hauswirth; Michel Michaelides; Joseph Carroll
TAGS: achromatopsia, artifacts, diagnostic imaging, ophthalmoscopy, optical coherence tomography, optics
Trans. Vis. Sci. Tech.. 2021; 10(1):11. https://doi.org/10.1167/tvst.10.1.11

Includes: Supplemental Content

ARVO Annual Meeting Abstract June 2020

Patient and caregiver experiences of functional vision impairment and health-related quality of life limitations associated with hereditary retinitis pigmentosa

Christine Kay; Judit Banhazi; Nicola Williamson; Rob Arbuckle; Chloe Tolley; Claudio Spera; Jane Green; M Dominik Fischer; Isabelle S Audo; Francesco Patalano; Daniel Viriato

Invest. Ophthalmol. Vis. Sci.. 2020; 61(7):1562.

ARVO Annual Meeting Abstract June 2020

Baseline visual fields in the RUSH2A study: Associated factors and correlation with measures of disease severity

Jacque L Duncan; Wendi Liang; Isabelle S Audo; David G Birch; Joseph Carroll; Janet K. Cheetham; Laura R Erker; Frederick L Ferris; Elise Heon; Robert Hufnagel; Alessandro Iannaccone; Glenn J Jaffe; Christine N Kay; Maureen Maguire; Michel Michaelides; Mark E Pennesi

Invest. Ophthalmol. Vis. Sci.. 2020; 61(7):3364.

ARVO Annual Meeting Abstract June 2020

Optical coherence tomography artifacts predict adaptive optics scanning light ophthalmoscopy success in achromatopsia

Katie M Litts; Erica N. Woertz; Rachel E Linderman; Byron L Lam; Gerald A Fishman; Mark E Pennesi; Christine N Kay; William W Hauswirth; Joseph Carroll

Invest. Ophthalmol. Vis. Sci.. 2020; 61(7):5271.

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Endpoints and Design for Clinical Trials in USH2A -Related Retinal Degeneration: Results and Recommendations From the RUSH2A Natural History Study

Gildeuretinol Enables the Vitamin A Cycle

Gildeuretinol Arrested Stargardt Disease, The TEASE-3 Study

Longitudinal imaging of the parafoveal cone mosaic in congenital achromatopsia

Photoreceptor structure following gene therapy in CNGA3 -mediated Achromatopsia: adaptive optics imaging results from a Phase 1/2 dose escalation clinical trial for AGTC-402 (rAAV2tYF-PR1.7-hCNGA3)

Overcoming the Challenges to Clinical Development of X-Linked Retinitis Pigmentosa Therapies: Proceedings of an Expert Panel

Interim results for the Phase 1/2 PRISM Trial evaluating 4D-150, a dual-transgene intravitreal genetic medicine in individuals with neovascular (wet) age-related macular degeneration

Six-month safety and efficacy of ATSN-101 in patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1)

Psychometric validation of patient-reported outcome (PRO) and observer-reported outcome (ObsRO) measures in Retinitis Pigmentosa and Leber Congenital Amaurosis

Findings on visual photosensitivity in two phase 1/2 clinical trials of subretinal gene therapy with AGTC-401 and AGTC-402 for CNGB3 and CNGA3 achromatopsia

Generation of qualitative evidence to support the content validity of the ViSIO-PRO and ViSIO-ObsRO in Retinitis Pigmentosa and Leber Congenital Amaurosis

Interim Safety Results in Two Phase 1/2 Open-label, Dose-escalation Clinical Trials of Subretinal Gene Therapy with AGTC-401 (rAAV2tYF-PR1.7-hCNGB3) and AGTC-402 (rAAV2tYF-PR1.7-hCNGA3) in Subjects with Achromatopsia (ACHM)

Qualitative interviews with patients and caregivers regarding visual function impairments and impacts on vision-dependent activities of daily living and health-related quality of life in RPE65-related Retinitis Pigmentosa and Leber Congenital Amaurosis

Twelve-month Findings from Two Phase 1/2 Clinical Studies of Subretinal Gene Therapy Drugs for Achromatopsia

Visual function improvements with BIIB112 (NSR-RPGR) in X-linked retinitis pigmentosa: XIRIUS (dose-expansion) and XOLARIS (natural disease progression) studies

Examining Whether AOSLO-Based Foveal Cone Metrics in Achromatopsia and Albinism Are Representative of Foveal Cone Structure

Optical Coherence Tomography Artifacts Are Associated With Adaptive Optics Scanning Light Ophthalmoscopy Success in Achromatopsia

Patient and caregiver experiences of functional vision impairment and health-related quality of life limitations associated with hereditary retinitis pigmentosa

Baseline visual fields in the RUSH2A study: Associated factors and correlation with measures of disease severity

Optical coherence tomography artifacts predict adaptive optics scanning light ophthalmoscopy success in achromatopsia

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