Status:
COMPLETED
Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Lucentis Monotherapy to Treat Age-Related Macular Degeneration
Lead Sponsor:
Bay Area Retina Associates
Collaborating Sponsors:
QLT Inc.
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 a...
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 (0.05cc) intravitreal dexamethasone injection (10mg...
Eligibility Criteria
Inclusion
- Best Corrected Visual Acuity using ETDRS Charts between 20/32 and 20/400 (Snellen Equivalent) in the study eye with evidence of neovascular ARMD.
- (Only one eye will be eligible for study. If both eyes are eligible, the one with the better visual acuity will be selected for treatment unless, based on medical reasons, the investigator deems the other eye to be more appropriate for treatment and study.)
- All lesion subtypes will be enrolled with the following criteria
- Predominantly classic:
- Classic lesion greater than 50% of the total lesion area
- Lesion must be less than 12 disc areas
- Minimally classic or occult:
- CNVM must be greater than or equal to 50% of the total lesion size.
- There must be some evidence of recent disease progression (heme, vision loss, recent lesion growth on FA)
- Lesion size must be less than 12 disc areas.
- Occult:
- Lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid
- Less than 12 disc areas in total size
- Signed informed consent
- Age greater than or equal to 50 years
Exclusion
- Pigment epithelial detachment greater than 50% of the total lesion size
- Previous treatment for ARMD in the study eye
- Previous intravitreal drug delivery in the study eye
- History of vitrectomy in the study eye
- Fibrosis or atrophy involving the center of the fovea in the study eye
- Neovascular membrane from any other concurrent retinal disease such as high myopia (SER \> -8D), histoplasmosis or other ocular inflammatory disease.
- Known history of glaucoma and on more than one topical medication
- History of glaucoma filtering surgery in the study eye
- History of corneal transplant in the study eye
- Patients with co-existing macular disease such as diabetic macular edema
- Active intraocular inflammation in the study eye
- History of allergy to fluorescein not amenable to treatment
- Inability to comply with study or follow up procedures
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00390208
Start Date
August 1 2006
End Date
December 1 2009
Last Update
May 27 2010
Active Locations (4)
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1
Bay Area Retina Associates
Castro Valley, California, United States, 94546
2
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
3
Georgia Retina
Riverdale, Georgia, United States, 30274
4
Retina Vitreous Associates
Toledo, Ohio, United States, 43608