Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331253
Status:
UNKNOWN
Last Update Posted:
2007-04-27
First Post:
2006-05-26
Brief Title:
Treatment of Patients With Neovascular AMD Using Indocyanine Green-Mediated Photothrombosis i-MP
Sponsor:
Opto Eletronica SA
Organization:
Opto Eletronica SA
Study Overview
Official Title:
A 54-WEEK PHASE 2 MULTICENTER MASKED RANDOMIZED CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INDOCYANINE GREEN-MEDIATED PHOTOTHROMBOSIS i-MP FOR THE TREATMENT OF PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
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:
None
Brief Summary:
To establish the safety and efficacy of indocyanine green-mediated photothrombosis i-MP for the treatment of patients with neovascular age-related macular degeneration
Detailed Description:
Comparative controlled multicenter masked randomized study three parallel groups comparing the Indocyanine Green-Mediated Photothrombosis to two control groups for the treatment of neovascular Age-Related Macular Degeneration
Only patients matching the following criteria are eligible
A BCVA worse than 2080 and neovascular complex with some component of occult CNV as defined by the fluorescein angiography or B BCVA worse than 2080 and neovascular complex with total area of CNV classic and occult by fluorescein angiography occupying an area lesser than 50 of the neovascular complex or C BCVA worse than 20200 and neovascular complex with some CNV classic OR occult by fluorescein angiography
The eligibility of the patients will be assessed by an independent Centre of Interpretation after masked analysis
Eligible patients will be allocated into one of the three study groups randomized at 211 proportion
Group 1 Treatment Procedure 1 i-MP ICG Laser at proportion of 2 In this group the patients will be submitted to endovenous infusion of ICG followed by irradiation with diode laser
Group 2 Treatment Procedure 2 Distilled water Laser at proportion of 1 In this group the patients will receive endovenous placebo infusion distilled water followed by irradiation with diode laser with same power utilized in Group 1
Group 3 Treatment Procedure 3 Distilled water Sham Laser at proportion of 1 In this group the patients will receive endovenous placebo infusion distilled water followed by simulated application of laser
Only patients matching the following criteria are eligible
A BCVA worse than 2080 and neovascular complex with some component of occult CNV as defined by the fluorescein angiography or B BCVA worse than 2080 and neovascular complex with total area of CNV classic and occult by fluorescein angiography occupying an area lesser than 50 of the neovascular complex or C BCVA worse than 20200 and neovascular complex with some CNV classic OR occult by fluorescein angiography
The eligibility of the patients will be assessed by an independent Centre of Interpretation after masked analysis
Eligible patients will be allocated into one of the three study groups randomized at 211 proportion
Group 1 Treatment Procedure 1 i-MP ICG Laser at proportion of 2 In this group the patients will be submitted to endovenous infusion of ICG followed by irradiation with diode laser
Group 2 Treatment Procedure 2 Distilled water Laser at proportion of 1 In this group the patients will receive endovenous placebo infusion distilled water followed by irradiation with diode laser with same power utilized in Group 1
Group 3 Treatment Procedure 3 Distilled water Sham Laser at proportion of 1 In this group the patients will receive endovenous placebo infusion distilled water followed by simulated application of laser
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