Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion (NCT02614937) | Clinical Trial Compass
CompletedPhase 1/2
Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion
20 participantsStarted 2013-04
Plain-language summary
This was a prospective, single center, open label, randomized study evaluating the biological effect of squalamine lactate ophthalmic solution, 0.2% combined with intravitreous ranibizumab in patients with macular edema secondary to branch, hemi-central and central retinal vein occlusion (BRVO, HRVO, CRVO).
Who can participate
Age range
40 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:
* Eyes with treatment naïve, center involving macular edema secondary to BRVO, HRVO or CRVO in patients of at least 40 years of age
* Macular edema of 1-4 months duration prior to the baseline visit
* Best corrected baseline ETDRS visual acuity of 20/40 to 20/320 Snellen equivalent using the 4 meter testing method
* Baseline CST greater than or equal to 325uM using SD-OCT imaging
* Less than 50% foveal capillary ring disruption as defined by fluorescein angiography (FA)
* Absence of dense intraretinal or subretinal hemorrhage and or lipid through the foveal center
* Absence of subfoveal fibrosis or hyperpigmentation.
Exclusion Criteria:
* Eyes with ocular pathology other than RVO related macular edema such as clinically significant cataract or media opacity, diabetic retinopathy, macular degeneration, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or intraocular tumor
* Intraocular surgery within 6 months prior to baseline
* Two-plus or greater afferent pupillary defect (APD) in the study eye
* Likelihood of evidence driven indication for peripheral scatter photocoagulation within 6 months of recruitment
* History of previous intravitreal pharmacologic treatment of any kind in the study eye
* History of previous retinal laser photocoagulation of any kind in the study eye
* History of intravitreal anti-VEGF therapy in the fellow eye within 6 months prior to baseline
* Any evidence of baseline ocular neovascularization such as disc neovasc…
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.