This extension study aims to collect long-term data on safety and efficacy in a subject population treated for ROP with aflibercept and/or laser, and to contribute to the clarification of potential effects.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Binocular best-corrected visual acuity in Snellen equivalent at 5 years of
age.
- Proportion of subjects with ocular AEs and SAEs up to 5 years of age.
- Proportion of subjects with systemic AEs and SAEs up to 5 years of age.
Secondary outcome
- Proportion of subjects developing unfavorable ocular structural outcome at
1,3 and 5 years of age. Unfavorable ocular structural outcome
include: retinal detachment, macular dragging, macular fold, retrolental
opacity.
- Proportion of subjects with absence of active ROP at 1 year of age.
- Proportion of subjects with unfavorable structural outcomes at 1 year of age.
- Best-corrected visual acuity in each eye at 3 and 5 years of age.
- Refractive spherical equivalent in each eye at 3 and 5 years of age.
- Neurodevelopmental outcomes using standardized development tests (BSID-III,
DAS-II, WPPSI-IV, VABS-II) at 2 and 5 years of age.
- Proportion of subjects with recurrence of ROP at 3 and 5 years of age.
- Proportion of subjects requiring treatment for ROP up to 5 years of age.
- Proportion of subjects requiring ophthalmological treatment up to 5 years of
age.
Background summary
The long-term effects of laser photocoagulation for the treatment of ROP is
known, including irreversible loss of visual field and high myopia. The purpose
of the current study is to primarily collect the missing data of the potential
long-term effects after treatment with aflibercept and laser. Subjects will be
followed to 5 years of age, which will enable a detailed assessment of visual
function and overall development.
Study objective
This extension study aims to collect long-term data on safety and efficacy in a
subject population treated for ROP with aflibercept and/or laser, and to
contribute to the clarification of potential effects.
Study design
This is a Phase 3b, multi-center study to assess the long-term outcomes of
subjects previously diagnosed with ROP who were treated in Study 20090. No
study treatment is defined to be administered during this study. The study
interventions being assessed were administered in Study 20090 (aflibercept
and/or laser photocoagulation). Any potential non-study treatments are to be
decided by the treating physician, according to local standards of care. The
screening/baseline visit of Study 20275 can be conducted concomitantly with the
Week 24 visit or the last follow-up visit of Study 20090, whichever is later,
or at a later point between this date and before the subject is 13 months of
chronological age. Additional visits will be scheduled at 40 wks and according
to the subject*s yearly birthday (±1 month), with the last visit at the
subject*s 5th birthday (±1 month).
Study burden and risks
Study participation includes routine physical, neurological, and ophthalmologic
examinations that are generally accepted as standards of care. The follow-up
planned in this study will be beneficial in assessing the long-term development
of subjects who were treated with aflibercept and/or laser photocoagulation in
Study 20090. Participation in the study involves approximately 7 visits in a
time period of 5 years. Risks associated with ophthalmological examinations are
low and are mainly related to pupil dilation (widening), including allergic
reactions to eye drops and temporary blurred vision. Examinations including eye
examinations and physical exams, will be performed at specific visits as
described in the protocol and the patient information and informed consent
forms.
Energieweg 1
Mijdrecht 3641RT
NL
Energieweg 1
Mijdrecht 3641RT
NL
Listed location countries
Age
Inclusion criteria
Subjects are eligible to be included in the study only if the following
criteria apply: 1.Subject was treated in Study 20090, 2.Age less than 13 months
of chronological age, 3.Signed informed consent from parent(s)/legally
authorized representative(s) as described in Section 10.1.3 of the clinical
trial protocol, which includes compliance with the requirements and
restrictions listed in the informed consent form (ICF) and in the protocol
Exclusion criteria
Subjects are excluded from the study if the following criterion applies:
Medical Conditions, 1. Subject has a condition preventing participation in the
study, or performance of study procedures
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-003180-54-NL |
| CCMO | NL69814.056.19 |