Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT00831350
Eligibility Criteria:
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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00831350
Study Brief:
Protocol Section:
NCT00831350