Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557369
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-24
Brief Title:
A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Proof-of-Concept Clinical Investigation to Evaluate Safety and Effectiveness of reSEES in Patients With Intermediate Age-Related Macular Degeneration
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
retinaSEES-PoC
Brief Summary:
The proposed clinical investigation wants primary to validate the safety of the innovative light therapy approach and in second priority provide insight and confirmations on therapeutic effect
By combining two clinically standard laser-light treatment both exhibiting a solid-safe profile the photothermal and the photobiological techniques the investigational device reSEES wants to explore a completely new therapeutic approach by synergically take advantage of the inherent and already observed clinical performances of the two independent techniques
By combining two clinically standard laser-light treatment both exhibiting a solid-safe profile the photothermal and the photobiological techniques the investigational device reSEES wants to explore a completely new therapeutic approach by synergically take advantage of the inherent and already observed clinical performances of the two independent techniques
Detailed Description:
Objectives
1 The primary objective is to evaluate the safety of the reSEES treatment
2 The secondary objective is to evaluate the effect of the reSEES treatment on the progression of intermediate AMD
Progression of intermediate AMD will be followed for one year
The contralateral eye will be used as a control to compare and observe relative and absolute progression and rate of progression
Other objectives
Evaluate the evolution of AMD-induced retinal morphological changes
Evaluate changes at the choriocapillaris vascular network and analysecompare eventual transition to nAMD with natural history
Evaluate the effect of reSEES on retina functional parameters
Investigate the effect of reSEES on patients perceived vision mood and general well-being
Evaluate the usability of the proposed laser console
Study Details
30 patients are planned to be included in the study Enrolled patients will receive treatment on the left or the worst eye and the fellow eye will be used as a control Enrolled patients must have both eyes eligible for the study rf Inclusion Criteria
Measurements Procedures
The measurements and procedures will be performed within 52 weeks
Total number of visits 10
Total number of treatments 9 General health medical history and concomitant medication will be assessed and reported
Ophthalmic examinations will be carried out at different time points at screening on Days 3 10 and 17 and at the follow-up visits at 18 24 and 52 weeks from T0 Adverse events and occurring changes in concomitant medication will also be collected for evaluation at every time point
1 The primary objective is to evaluate the safety of the reSEES treatment
2 The secondary objective is to evaluate the effect of the reSEES treatment on the progression of intermediate AMD
Progression of intermediate AMD will be followed for one year
The contralateral eye will be used as a control to compare and observe relative and absolute progression and rate of progression
Other objectives
Evaluate the evolution of AMD-induced retinal morphological changes
Evaluate changes at the choriocapillaris vascular network and analysecompare eventual transition to nAMD with natural history
Evaluate the effect of reSEES on retina functional parameters
Investigate the effect of reSEES on patients perceived vision mood and general well-being
Evaluate the usability of the proposed laser console
Study Details
30 patients are planned to be included in the study Enrolled patients will receive treatment on the left or the worst eye and the fellow eye will be used as a control Enrolled patients must have both eyes eligible for the study rf Inclusion Criteria
Measurements Procedures
The measurements and procedures will be performed within 52 weeks
Total number of visits 10
Total number of treatments 9 General health medical history and concomitant medication will be assessed and reported
Ophthalmic examinations will be carried out at different time points at screening on Days 3 10 and 17 and at the follow-up visits at 18 24 and 52 weeks from T0 Adverse events and occurring changes in concomitant medication will also be collected for evaluation at every time point
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