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:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT00083967
Eligibility Criteria:
Inclusion Criteria:
* have rhegmatogenous retinal detachment in only one eye
* be able to receive intravitreal injection of study drug and be able to wait 24(+/- 6) hours to have detachment surgically treated or retinal breaks repaired per judgement of investigator
* no more than 3 separate identifiable retinal breaks that are clustered together and confined within an area no more than 2 clock hours in extent
* retinal detachment must be large enough such that it cannot be immediately repaired with laser photocoagulation or cryotherapy
* have pinhole acuity (using ETDRS) of macula-on, 20/50 or better in both eyes OR macula-off, 20/50 or better in non-study eye and have history, prior to detachment, of reading capability in study eye
Exclusion Criteria:
* have a non-rhegmatogenous retinal detachment
* have large retinal break(s) whose total break area is greater than 1 clock hour in extent
* have evidence of atrophic retinal pigment epithelium, choroid, choroidal detachment or intraocular inflammation
* be monocular
* have a prior retinal detachment repair or a congenital condition that places a greater risk for rhegmatogenous retinal detachment
* have proliferative vitreoretinopathy greater than grade B
* have pre-existing subretinal or vitreous hemorrhage, corneal opacity, or other conditions which limit the view of peripheral retina
* have any co-existing macular pathology or other retinal conditions that can limit visual acuity
* currently have uncontrollable elevated intraocular pressure, advanced glaucoma, or any history or current evidence of endophthalmitis in the affected eye
* have symptoms consistent with a rhegmatogenous retinal detachment such as visual disturbance greater than 14 days prior to screening if macula-on OR history of loss of reading vision in affected eye for greater than 6 days prior to screening if macula-off
* have a retinal detachment with evidence of demarcation lines or evidence of subretinal fibrosis visible upon fundus examination
* be currently taking medications that could obscure or confound study results including acetazolamide (Diamox) and dorzolamide
* have had a periocular, retrobulbar or intravitreal injection in the affected eye, including corticosteroids in the 3 months prior to screening or require one
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00083967
Study Brief:
Protocol Section:
NCT00083967