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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

A multicenter, open-labeled, phase 2a study of AG-73305, a novel bi-specific Fc-fusion protein for the treatment of diabetic macular edema

Tan Nguyen; Sunil Patel; Janet K Cheetham; David S Boyer; Artemis Wu; Larry A Wheeler; Madhu Cherukury

Invest. Ophthalmol. Vis. Sci.. 2024; 65(7):1759.

ARVO Annual Meeting Abstract June 2024

AG-80308, a novel first-in-class ophthalmic solution for the treatment of dry eye disease

Janet K Cheetham; Sandy Lai; Tan Nguyen; Sunil S Patel; Scott M Whitcup; Madhu Cherukury

Invest. Ophthalmol. Vis. Sci.. 2024; 65(7):2984.

Retina June 2024

Self-Reported Functional Vision in USH2A -Associated Retinal Degeneration as Measured by the Michigan Retinal Degeneration Questionnaire

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Bela Parekh; Jacque L. Duncan; Lassana Samarakoon; Michele Melia; Maria Fernanda Abalem; Chris A. Andrews; Isabelle Audo; Allison R. Ayala; Chris Bradley; Janet K. Cheetham; Gislin Dagnelie; Todd A. Durham; Rachel M. Huckfeldt; Gabrielle D. Lacy; Brett Malbin; Michel Michaelides; David C. Musch; Nicholas Peck-Dimit; Katarina Stingl; Christina Y. Weng; Alex Z. Zmejkoski; K. Thiran Jayasundera; for the Foundation Fighting Blindness Clinical Consortium Investigator Group
TAGS: michigan, questionnaires, retinal degeneration, self-report, vision, vision tests
Invest. Ophthalmol. Vis. Sci.. 2024; 65(6):5. https://doi.org/10.1167/iovs.65.6.5

Includes: Supplemental Content

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

Open-label Phase 2a study of AG-73305, a novel bi-specific Fc-fusion protein for the treatment of diabetic macular edema

Sunil Patel; Janet K Cheetham; Tan Nguyen; David S Boyer; Artemis Wu; Ben Chang; Larry A Wheeler; Madhu Cherukury

Invest. Ophthalmol. Vis. Sci.. 2023; 64(8):2642.

ARVO Annual Meeting Abstract June 2022

Visual acuity and full-field stimulus thresholds (FST) over 2 years in the RUSH2A study: annual rates of change from mixed effects modeling

Peiyao Cheng; David G Birch; Jacque L Duncan; Frederick L Ferris; Maureen G Maguire; Allison R. Ayala; Janet K Cheetham; Todd Durham; Abigail T Fahim; Rachel M Huckfeldt; Michel Michaelides; Mark E Pennesi; Jose Alain Sahel; Katarina Stingl; Ajoy Vincent; Christina Y Weng

Invest. Ophthalmol. Vis. Sci.. 2022; 63(7):4480 – F0267.

Retina March 2022

The RUSH2A Study: Dark-Adapted Visual Fields in Patients With Retinal Degeneration Associated With Biallelic Variants in the USH2A Gene

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David G. Birch; Lassana Samarakoon; Michele Melia; Jacque L. Duncan; Allison R. Ayala; Isabelle Audo; Janet K. Cheetham; Todd A. Durham; Alessandro Iannaccone; Mark E. Pennesi; Katarina Stingl; for the Foundation Fighting Blindness Consortium Investigator Group
TAGS: genes, retinal degeneration, rod photoreceptors, visual fields, illness length
Invest. Ophthalmol. Vis. Sci.. 2022; 63(3):17. https://doi.org/10.1167/iovs.63.3.17

ARVO Annual Meeting Abstract June 2021

Patient-reported visual functioning in persons with bi-allelic USH2A variants

Elise Heon; B. Michele Melia; Laura E Bocchino; Jacque L Duncan; Allison Ayala; Chris Bradley; Isabelle Audo; Janet K Cheetham; Gislin Dagnelie; Todd Durham; Carel Hoyng; Nieraj Jain; Thiran Jayasundera; Mark E Pennesi; Christina Y Weng

Invest. Ophthalmol. Vis. Sci.. 2021; 62(8):3541.

ARVO Annual Meeting Abstract June 2021

Dark-adapted visual fields (DAVF) in patients with two disease-causing variants in USH2A

David G Birch; Lassana Samarakoon; Laura E Bocchino; B. Michele Melia; Jacque L Duncan; Allison Ayala; Isabelle Audo; Janet K Cheetham; Todd Durham; Alessandro Iannaccone; Mark E Pennesi; Katarina Stingl

Invest. Ophthalmol. Vis. Sci.. 2021; 62(8):3241.

ARVO Annual Meeting Abstract June 2021

Auditory and olfactory findings from the Rate of Progression of USH2A -related Retinal Degeneration (RUSH2A) study

Alessandro Iannaccone; Carmen C. Brewer; Peiyao Cheng; Jacque L Duncan; Maureen G Maguire; Isabelle Audo; Allison Ayala; Paul S Bernstein; Gavin M. bidelman; Janet K Cheetham; Richard L. Doty; Todd Durham; Robert B Hufnagel; Mark H. Myers; Wadih M Zein

Invest. Ophthalmol. Vis. Sci.. 2021; 62(8):1537.

Perspective April 2021

Tackling the Challenges of Product Development Through a Collaborative Rare Disease Network: The Foundation Fighting Blindness Consortium

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Todd A. Durham; Jacque L. Duncan; Allison R. Ayala; David G. Birch; Janet K. Cheetham; Frederick L. Ferris, III; Carel B. Hoyng; Mark E. Pennesi; José-Alain Sahel; for the Foundation Fighting Blindness Consortium Investigator Group
TAGS: blindness, rare diseases
Trans. Vis. Sci. Tech.. 2021; 10(4):23. https://doi.org/10.1167/tvst.10.4.23

Articles October 2020

The RUSH2A Study: Best-Corrected Visual Acuity, Full-Field Electroretinography Amplitudes, and Full-Field Stimulus Thresholds at Baseline

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David G. Birch; Peiyao Cheng; Jacque L. Duncan; Allison R. Ayala; Maureen G. Maguire; Isabelle Audo; Janet K. Cheetham; Todd A. Durham; Abigail T. Fahim; Frederick L. Ferris, III; Elise Heon; Rachel M. Huckfeldt; Alessandro Iannaccone; Naheed W. Khan; Eleonora M. Lad; Michel Michaelides; Mark E. Pennesi; Katarina Stingl; Ajoy Vincent; Christina Y. Weng; for the Foundation Fighting Blindness Consortium Investigator Group
TAGS: electroretinography, visual acuity
Trans. Vis. Sci. Tech.. 2020; 9(11):9. https://doi.org/10.1167/tvst.9.11.9

Includes: Supplemental Content

ARVO Annual Meeting Abstract June 2020

Accelerating research in rare inherited retinal disorders (IRDs) through an international consortium

Janet K Cheetham; Allison Ayala; David G Birch; Jacque L Duncan; Todd Durham; Frederick L Ferris; Maureen Maguire; Mark E Pennesi

Invest. Ophthalmol. Vis. Sci.. 2020; 61(7):3356.

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

Test-retest variability of static perimetry and microperimetry results from the RUSH2A study

Allison Ayala; Wendi Liang; David G Birch; Janet K Cheetham; Elvira N Chegarnov; Jacque L Duncan; Todd Durham; Frederick L Ferris; Eleonora M Lad; Maureen Maguire; Mark E Pennesi

Invest. Ophthalmol. Vis. Sci.. 2020; 61(7):3342.

ARVO Annual Meeting Abstract July 2019

Using retinal structural measurements derived from optical coherence tomography as clinical endpoints for Stargardt disease - reproducibility assessment and lessons learned from the ProgStar study

Xiangrong Kong; Alexander Ho; Beatriz Munoz; Sheila K West; Rupert W Strauss; Anamika Jha; Ann Margret Ervin; Janet Cheetham; Michael S Ip; Hendrik P Scholl

Invest. Ophthalmol. Vis. Sci.. 2019; 60(9):3945.

Articles June 2019

Reproducibility of Measurements of Retinal Structural Parameters Using Optical Coherence Tomography in Stargardt Disease

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Xiangrong Kong; Alexander Ho; Beatriz Munoz; Sheila West; Rupert W. Strauss; Anamika Jha; Ann Ervin; Jeff Buzas; Mandeep Singh; Zhihong Hu; Janet Cheetham; Michael Ip; Hendrik P. N. Scholl
TAGS: optical coherence tomography, retina, spectral domain-optical coherence tomography, stargardt's disease, atrophy, eye, surrogate endpoints
Trans. Vis. Sci. Tech.. 2019; 8(3):46. https://doi.org/10.1167/tvst.8.3.46

Includes: Supplemental Content

New Developments in Vision Research April 2019

A Workshop on Measuring the Progression of Atrophy Secondary to Stargardt Disease in the ProgStar Studies: Findings and Lessons Learned

PDF

Ann-Margret Ervin; Rupert W. Strauss; Mohamed I. Ahmed; David Birch; Janet Cheetham; Frederick L. Ferris III; Michael S. Ip; Glenn J. Jaffe; Maureen G. Maguire; Etienne M. Schönbach; SriniVas R. Sadda; Sheila K. West; Hendrik P.N. Scholl; for the ProgStar Study Group
TAGS: atrophy, eye, spectral domain-optical coherence tomography, stargardt's disease, prospective studies
Trans. Vis. Sci. Tech.. 2019; 8(2):16. https://doi.org/10.1167/tvst.8.2.16

Research Opportunities July 2017

Report From the NEI/FDA Endpoints Workshop on Age-Related Macular Degeneration and Inherited Retinal Diseases

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Karl Csaky; Frederick Ferris, III; Emily Y. Chew; Prashant Nair; Janet K. Cheetham; Jacque L. Duncan
TAGS: retinal diseases, surrogate endpoints, united states food and drug administration, age-related macular degeneration, eye
Invest. Ophthalmol. Vis. Sci.. 2017; 58(9):3456-3463. https://doi.org/10.1167/iovs.17-22339

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

A multicenter, open-labeled, phase 2a study of AG-73305, a novel bi-specific Fc-fusion protein for the treatment of diabetic macular edema

AG-80308, a novel first-in-class ophthalmic solution for the treatment of dry eye disease

Self-Reported Functional Vision in USH2A -Associated Retinal Degeneration as Measured by the Michigan Retinal Degeneration Questionnaire

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

Open-label Phase 2a study of AG-73305, a novel bi-specific Fc-fusion protein for the treatment of diabetic macular edema

Visual acuity and full-field stimulus thresholds (FST) over 2 years in the RUSH2A study: annual rates of change from mixed effects modeling

The RUSH2A Study: Dark-Adapted Visual Fields in Patients With Retinal Degeneration Associated With Biallelic Variants in the USH2A Gene

Patient-reported visual functioning in persons with bi-allelic USH2A variants

Dark-adapted visual fields (DAVF) in patients with two disease-causing variants in USH2A

Auditory and olfactory findings from the Rate of Progression of USH2A -related Retinal Degeneration (RUSH2A) study

Tackling the Challenges of Product Development Through a Collaborative Rare Disease Network: The Foundation Fighting Blindness Consortium

The RUSH2A Study: Best-Corrected Visual Acuity, Full-Field Electroretinography Amplitudes, and Full-Field Stimulus Thresholds at Baseline

Accelerating research in rare inherited retinal disorders (IRDs) through an international consortium

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

Test-retest variability of static perimetry and microperimetry results from the RUSH2A study

Using retinal structural measurements derived from optical coherence tomography as clinical endpoints for Stargardt disease - reproducibility assessment and lessons learned from the ProgStar study

Reproducibility of Measurements of Retinal Structural Parameters Using Optical Coherence Tomography in Stargardt Disease

A Workshop on Measuring the Progression of Atrophy Secondary to Stargardt Disease in the ProgStar Studies: Findings and Lessons Learned

Report From the NEI/FDA Endpoints Workshop on Age-Related Macular Degeneration and Inherited Retinal Diseases

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