Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy
NCT06164587
Age-Related Macular Degeneration, Eye Diseases
Loma Linda, California, United States
View Trial DetailsNCT Number: NCT06499571
The purpose of this study is to describe functional and long-term clinical outcomes of patients with a diagnosis of Geographic Athrophy secondary to Age related Macular Degenaration in Clinical Practice
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Notify Me60 year and older
All sexes
Observational
Sydney West Retina, Westmead, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for patients:
Inclusion criteria
for caregivers:
Exclusion criteria
Exclusion criteria
for patients:
Exclusion criteria
for caregivers:
Time frame: Through study completion; between 4 and 11 years
Mean GA total area size and Mean change in GA total area size
Time frame: Through study completion; between 4 and 11 years
Mean BCVA and Mean change in BCVA
Time frame: Through study completion; between 4 and 11 years
Percentage of participants with moderate/severe visual impairment or blindness
Time frame: Through study completion; between 4 and 11 years
Percentage of participants with any microperimetry assessments since GA diagnosis
Time frame: Through study completion; between 4 and 11 years
Mean/Median and Mean change in retinal sensitivity.
Time frame: Through study completion; between 4 and 11 years
Mean/Median and Mean change in fixation stability.
Time frame: Through study completion; between 4 and 11 years
Mean/Median and Mean change in number of scotoma points.
Time frame: Through study completion; between 4 and 11 years
Percentage of eyes that complete any of the protocol-defined disease progression trajectories and Mean time from GA diagnosis to disease progression
Time frame: Through study completion; between 4 and 11 years
Proportion of GA eyes with presence of any of the following: nAMD, drusen, pseudodrusen, foveal involvement, unifocal/multifocal GA, hypopigmentation
Time frame: Through study completion; between 4 and 11 years
Proportion of non-GA eyes with presence of any of the following: early/intermediate AMD, nAMD, MNV
Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Mortality rate during study follow-up
Time frame: Through study completion; between 4 and 11 years
Number of medical visits (outpatient, low vision clinic, etc.)
Time frame: Through study completion; between 4 and 11 years
number of imaging tests (F, A, FAF, CFP, OCT, OCTA, etc.)
Time frame: Through study completion; between 4 and 11 years
number of prescribed vision aids, per participant
Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Score of the EQ-5D.
Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Score of the HADS
Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Score of the AQoL-7D for Australian sites only.
Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Scores/answers to the NEI-VFQ-25 questionnaire.
Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Scores/answers to the GALTOS survey.
Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Proportion of patients requiring support from an informal caregiver, receiving assisted care at home or in assisted living
Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
mean/median time from GA diagnosis to first type of assistance
Time frame: From enrollment until end of follow-up; 12 (+6) months after the follow-up period.
Selected items of the GALTOS survey (including the cost, in the past 12 months, associated to prescriptions, assistive devices, healthcare-related travel, etc.)
Time frame: Through study completion; between 4 and 11 years
Measures of association such as correlation coefficients, chi-square statistic, and potentially coefficients from multivariate analysis methods characterizing the relationships of interest
Apellis Pharmaceuticals, Inc.
Industry
G.A.L.T.O.S. Geographic Atrophy Long-Terms Outcomes Study: An Ambispective Noninterventional Study to Describe the Patient Demographics and Outcomes of Patients With Geographic Atrophy (GA) Secondary to AMD in Clinical Practice
Acronym: GALTOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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