Status:
COMPLETED
Posterior Vitreous Detachment (PVD) Assessment During Dual Retinal Vein Occlusion (RVO) Lucentis Evaluations
Lead Sponsor:
Barnes Retina Institute
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Retinal Vein Occlusion
Posterior Vitreous Detachment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. Poster...
Detailed Description
Several retinovascular diseases have been shown to be VEGF dependent including retinal vein occlusion, wet age-related macular degeneration, and diabetic retinopathy. The role of the vitreous or compo...
Eligibility Criteria
Inclusion
- 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
- 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 use of systemic anti-VEGF agents
- Has active infection in the study eye.
- Inability to obtain photographs.
- Has received investigational therapy within 60 days prior to study entry.
- Patients with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Has other conditions the investigator considers to be sound reasons for exclusion (e.g., lack of motivation, history of poor compliance, concomitant illnesses, personality disorder, mental condition, drug abuse, use of neuroleptics, physical or social condition predicting difficulty in long-term follow-up).
- Has an allergy to fluorescein sodium dye.
- Inability to comply with study or follow-up procedures.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00831350
Start Date
April 1 2009
End Date
December 1 2012
Last Update
October 30 2017
Active Locations (1)
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1
Barnes Retina Institute
St Louis, Missouri, United States, 63110