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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT01370135
Eligibility Criteria:
Inclusion Criteria:
1. neo-vascular glaucoma or rubeosis
* definition of neo-vascular glaucoma: patient with iris neovascularization with intraocular pressure elevation (exceeding 21 mmHg)
* definition of rubeosis: patient with iris neovascularization without intraocular pressure elevation (≤21 mmHg)
2. an available follow-up of 12 months
3. written informed consent
4. visual acuity of light perception or better.
Exclusion Criteria:
1. history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
2. clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
3. ventricular tachyarrhythmias requiring ongoing treatment
4. History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
5. Clinically significant impaired renal or hepatic function
6. Stroke within 12 month before trial entry.
7. Known serious allergies to the fluorescein dye use in angiography
8. Known contraindications to the components of Lucentis® formulation.
Ocular concomitant conditions/ diseases
1. Active intraocular inflammation (grade trace or above) in either eye
2. Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
3. History of uveitis in either eye
4. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, ranibizumab, etc.) or intravitreal corticosteroids in either eye within 4 months prior to inclusion
5. Angle block glaucoma
6. Phthisis
7. Intraocular Pressure \<10mmHg
Compliance/ Administrative
1. Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to inclusion
2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
3. Pregnant or nursing (lactating) women
4. Inability to comply with study or follow-up procedures.
5. Any treatment with an investigational agent in the past 60 days for any condition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01370135
Study Brief:
Protocol Section:
NCT01370135