Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390208
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2006-10-17
Brief Title:
Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Lucentis Monotherapy to Treat Age-Related Macular Degeneration
Sponsor:
Bay Area Retina Associates
Organization:
Bay Area Retina Associates
Study Overview
Official Title:
A Prospective Masked Pilot Study Comparing Group 1 Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Group 2 Monotherapy - Intravitreal Ranibizumab Alone
Status:
COMPLETED
Status Verified Date:
2010-05
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:
PDEX
Brief Summary:
The purpose of this study is to compare triple therapy using Photodynamic therapy intravitreal Dexamethasone and intravitreal Ranibizumab injections versus monotherapy with intravitreal Ranibizumab alone for the treatment of Age-Related Macular Degeneration
Detailed Description:
This is a twelve month Phase II prospective masked study comparing Group 1 triple therapy Same day combination therapy with PDT 500 microgram dose 005cc intravitreal dexamethasone injection 10mgml vial and a single 05 mg intravitreal Ranibizumab injection This will be compared to Group 2 monotherapy one intravitreal injection of 05 mg Lucentis given every four weeks on a set dosing schedule Sixty consecutive patients will be enrolled into this clinical trial utilizing the current standard of care guidelines as used at Bay Area Retina Associates Angiography fundus photography will be performed at the initial visit and quarterly follow-up visits Only OCT testing will be performed at all other follow-up visits Both groups will be re-evaluated for safety at 12 and 24 months
Group 1 Following the initial treatment all future re-treatments with Lucentis will be determined on a PRN basis The decision will be based on clinical examination and imaging evidence of lesion activity Any evidence of subretinal fluid or cystoid edema on OCT or clinical examination or evidence of leakage on angiogram will result in re-treatment If after three consecutive Ranibizumab injections in Group 1 there is any evidence of lesion recurrence or growth of the neovascular membrane associated with visual decline or persistent subretinal fluid the patient will be treated with repeat PDTIVDLucentis The decision to retreat Group 1 with ranibizumab at each monthly follow-up visit will be dependent on clinical exam OCT measurements or angiographic findings as documented below
Group 2 Subjects will receive one intravitreal injection of 05 mg Lucentis every four weeks until week 48 or as indicated on the FDA approval label
Group 1 Following the initial treatment all future re-treatments with Lucentis will be determined on a PRN basis The decision will be based on clinical examination and imaging evidence of lesion activity Any evidence of subretinal fluid or cystoid edema on OCT or clinical examination or evidence of leakage on angiogram will result in re-treatment If after three consecutive Ranibizumab injections in Group 1 there is any evidence of lesion recurrence or growth of the neovascular membrane associated with visual decline or persistent subretinal fluid the patient will be treated with repeat PDTIVDLucentis The decision to retreat Group 1 with ranibizumab at each monthly follow-up visit will be dependent on clinical exam OCT measurements or angiographic findings as documented below
Group 2 Subjects will receive one intravitreal injection of 05 mg Lucentis every four weeks until week 48 or as indicated on the FDA approval label
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