Ignite Creation Date:
2024-05-06 @ 7:34 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02557451
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2015-09-16
Brief Title:
Surgery Tissue Plasminogen Activator Antiangiogenic Agents and Age Related Macular Degeneration Complications
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
Subretinal Haematoma in AMD Randomized Controlled Study of 2 Therapeutic Approaches in the Antiangiogenic Era
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief Summary:
AMD is a disease of the central retina a zone that enables fine detail activities reading detail This central zone of the retina can be affected by a haemorrhagic complication when small abnormal vessels suddenly start to bleed inside the retina Several therapeutic approaches are currently available even though they have never been truly compared The study will be proposed to patients who need to be treated for haemorrhage of the macula A certain number of factors will be evaluated to compare the 2 principal approaches currently used in France surgery followed by injections of an anti-angiogenic OR intravitreal injections of gas followed by injections of anti-angiogenics This is a multicentre randomized controlled trial to compare these 2 therapeutic approaches
These diametrically opposed approaches have very different consequences for patients and in terms of cost for society The consequences for patients will be immediately measurable so as to determine the best therapeutic approach in terms of functional recovery and the impact of the disease on quality of life while taking into account the risks inherent to these 2 treatments The impact on quality of life of these 2 approaches as well as their consequences - an important factor in this disease which is a cause of sensory handicap - will provide the ophthalmological community with essential information making it possible to validate one or the other of these methods for the management of these haematomas
These diametrically opposed approaches have very different consequences for patients and in terms of cost for society The consequences for patients will be immediately measurable so as to determine the best therapeutic approach in terms of functional recovery and the impact of the disease on quality of life while taking into account the risks inherent to these 2 treatments The impact on quality of life of these 2 approaches as well as their consequences - an important factor in this disease which is a cause of sensory handicap - will provide the ophthalmological community with essential information making it possible to validate one or the other of these methods for the management of these haematomas
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None