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). Twenty consented patients with acute CME after phacoemulsification cataract surgery with posterior chamber intraocular lens implantation (PE/PCIOL) will be randomized 1:1 to treatment with R or T. R patients will receive three monthly R injections, followed by PRN dosing. T patients will receive PRN injections every 3 months. Clinical CME is defined as clinically evident CME, with visual acuity (VA) typically in the 20/40 to 20/200 range. Re-treatment criteria will include clinically evident worsening of CME, combined with any of the following:
* Any increase in spectral domain ocular coherence tomography (OCT) central macular thickness (CMT)
* Any observable fluid on OCT
* Any qualitatively increased perifoveal leakage/pooling on fluorescein angiography (FA).
Patients will be followed monthly through 12 months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
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 s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SAFETY of INTRAVITREAL RANIBIZUMAB VS. TRIAMCINOLONE ACETONIDE FOR ACUTE PSEUDOPHAKIC CYSTOID MACULAR EDEMA TREATMENT (Incidence and severity of ocular adverse events)