Status:
COMPLETED
A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet AMD
Lead Sponsor:
Subhransu K. Ray, M.D., Ph.D.
Collaborating Sponsors:
Bay Area Retina Associates
Conditions:
Exudative Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this proposed research study is to evaluate the safety of intravitreal ranibizumab in combination with intravitreal dexamethasone in comparison to intravitreal ranibizumab alo...
Detailed Description
A prospective, single masked comparative trial using either combination therapy (group 1): same day combination therapy with 0.05cc intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5...
Eligibility Criteria
Inclusion
- • Best Corrected Visual Acuity at 4 meters 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 and minimally classic: Angiographic lesion greater than 50% of the total lesion area Occult: Lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid
- Signed informed consent
- Age greater than or equal to 50 years
Exclusion
- Previous treatment for ARMD in the study eye
- Previous intravitreal drug delivery in the study eye
- Previous 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 active 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
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Inability to comply with study or follow up procedures
- Participation in another simultaneous medical investigation or trial
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00793923
Start Date
January 1 2008
End Date
December 1 2012
Last Update
December 19 2012
Active Locations (1)
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1
Bay Area Retina Associates
Walnut Creek, California, United States, 94598