This is a study of subjects with retinal vein occlusion (RVO) specifically looking at the difference in outcomes between patients with posterior vitreous detachment (PVD) and those without PVD. Posterior vitreous detachment is a condition where the gel-like substance that occupies the space between the retina and the lens of the eye liquefies and separates from the retina. 20 subjects from Barnes Retina Institute will be enrolled in this study. Based on a pre-treatment ultrasound (a test utilizing high-frequency sound waves to look at the inside of the eye), high resolution OCT (a noninvasive procedure called optical coherence tomography to check the thickness of your retina) and clinical exam, subjects will be assigned to one of 2 groups at baseline: Group 1 will be those with PVD and Group 2 will be those without PVD. Then subjects will receive monthly intravitreal (inside the eye) injections of Ranibizumab.
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:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Subjects of either gender, Age \> 18 years
* Best corrected visual acuity in the study eye between 20/40 and 2/200 inclusive.
* Retinal venous occlusive disease (BRVO or CRVO)
* Clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography, scheimpflug photography and high resolution OCT
* Ability to return for all study visits
Exclusion Criteria:
* 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.
* Prior RVO in the study eye
* Duration of RVO greater than 6 months
* Laser photocoagulation for macular edema within 3 months of Day 0
* Patients prior eye treatment including anti-VEGF therapy (within 3 months) or, intravitreal corticosteroid therapy (within 6 months)
* Prior vitreoretinal surgery.
* Had ocular surgery within the past 60 days in the study eye.
* Concurrent use of more than two therapies for glaucoma.
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure \>30 mm Hg despite treatment with anti-glaucoma medication).
* Neovascular glaucoma
* Concurrent us…
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.
1This trial looked at whether having a posterior vitreous detachment (PVD) affected how well ranibizumab (Lucentis) worked for retinal vein occlusion — what did the results show, and does my PVD status change how you'd expect me to respond to this treatment?
2Since this was a Phase 2 trial that has already completed, have the findings been published, and how confident are you in the safety and effectiveness data compared to what's available from larger, later-stage studies of ranibizumab for RVO?
3The trial measured vision improvement over 6 months — is that timeframe long enough to understand how my vision might hold up over the longer term, and what happens to patients after that 6-month window?
4Since this trial specifically separated patients into PVD-positive and PVD-negative groups, do you know which group tended to do better, and have you checked whether I have a PVD so we can factor that into my treatment plan?
5Given that this trial is now completed and I wasn't part of it, are there currently open trials or standard-of-care options for RVO that might be a better fit for me based on what this and similar studies found?
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
Mean change in BCVA at 6 months in the PVD positive and PVD negative ranibizumab-treated groups.