Status:
UNKNOWN
Treat and Extend Analysis Trial With Aflibercept in Wet-AMD
Lead Sponsor:
Michel Giunta
Collaborating Sponsors:
Bayer
Conditions:
Wet Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
This study is a randomized, prospective, exploratory, descriptive, open label, parallel group, post-authorization study designed to describe and evaluate two aflibercept treatment regimens aimed at ac...
Eligibility Criteria
Inclusion
- Patient who are able to give written informed consent
- Patients 50 years of age or older
- Patients with a diagnosis of treatmenttreatment-naive CNV secondary to AMD in the study eye, for which aflibercept treatment hashas been prescribed by the treating physician. This includes patients with lesion(s) with less than 50% hemorrhage, less that 50% fibrosis, and/or serious pigment epithelial detachment (PED)
- Patients with best corrected visual acuity score in the study eye between 78 and 19 letters inclusively, using ETDRS visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/400 at screening)
- Females of childbearing potential must, in the opinion of the Investigator, be using a medically effective method of contraception to prevent pregnancy and agree to use an acceptable method of contraception for the duration of their participation in this study. Effective contraception should be used by subjects during the study and for three months after treatment. Effective methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception.
Exclusion
- Patients with a structural foveal damage - advanced sub retinal fibrosis or significant geographic atrophy involving the foveal center (lack of morphological reserve) in the study eye
- Patients with confounding severe ocular disease in the study eye (such as uncontrolled glaucoma, diabetic retinopathy likely to be visually significant within 2 years, cataract presumably requiring surgery within 2 years) -vitreous or pre-retinal haemorrhage obscuring the central macula, or presence of rhegmatogenous retinal detachment
- Patients with clinical suspicion of polypoidal choroidal vasculopathy
- Patients with active or suspected ocular per ocular infections in either eye
- Patients with active intraocular inflammation in either eye
- Patients with a known sensitivity to Aflibercept or any component of its formulation
- Patients physically unable to tolerate intravenous fluorescein angiography
- Pregnant or breastfeeding female patients
- Any patient with recent history of new onset cardiac disease or thromboembolic event (within 12 months of Baseline visit)
- Patients having received systemic treatment with any other anti-VEGF therapy 60 days prior to enrollment
- Patients having had any prior treatment in the study eye (Avastin, Lucentis, Visudyne, Ozurdex, external radiation therapy, transpupillary thermotherapy, or any intravitreal injection)
- Concurrent participation in a clinical trial or within 30 days prior to enrollment
- Patients with any other condition which, in the opinion of the principal investigator, would require treatment that would significantly impact the treatment assessments during the study.
Key Trial Info
Start Date :
July 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04113538
Start Date
July 24 2019
End Date
May 1 2023
Last Update
June 14 2022
Active Locations (1)
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1
GOGIUNTA
Sherbrooke, Quebec, Canada, J1G 2V4