Status:
COMPLETED
Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide
Lead Sponsor:
Soll Eye
Collaborating Sponsors:
Genentech, Inc.
Conditions:
CYSTOID MACULAR EDEMA
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, Phase I/II study evaluating intravitreal ranibizumab (R) vs. intravitreal Triesence (triamcinolone acetonide) (T) in subjects with acute pseudophakic cystoid macular edema (CME)...
Detailed Description
1. BACKGROUND 1.1 PATHOPHYSIOLOGY Despite improved cataract surgery instrumentation and techniques, the incidence of clinical CME remains 1 - 3% following uncomplicated PE/PCIOL. CME remains t...
Eligibility Criteria
Inclusion
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 18 years
- Treatment naive subjects with a history of uncomplicated cataract surgery within 3 months of referral for treatment and a diagnosis of CME secondary to cataract surgery within 1 month of referral for treatment.
- Best corrected ETDRS VA of 20/40 - 20/400.
- Spectral domain OCT central retinal thickness \> 300 microns.
Exclusion
- Subjects who meet any of the following criteria will be excluded from this study:
- Any prior treatment for CME secondary to cataract surgery including but not limited to pre or post-operative corticosteroids, NSAIDS, etc.
- Subject has significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy
- Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, etc.
- History of allergy to fluorescein, not amenable to treatment
- History of glaucoma surgery
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Concurrent use of systemic anti-VEGF agents
- Have received any other systemic experimental drug within 12 weeks prior to enrollment.
- Currently being treated for active systemic infection
- Inability to comply with study or follow-up procedures.
- Patient has a condition that, in the opinion of the investigator would preclude participation in the study (i.e. chronic alcoholism, drug abuse)
- Pregnancy (positive pregnancy test) or lactation
- Pre-menopausal 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
- Participation in another simultaneous medical investigation or trial
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02294656
Start Date
November 1 2014
End Date
September 1 2018
Last Update
September 11 2018
Active Locations (1)
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1
Soll Eye
Philadelphia, Pennsylvania, United States, 19116