A Study of an Encapsulated Cell Technology (ECT) Implant for Patients With Atrophic Macular Degen… (NCT00447954) | Clinical Trial Compass
CompletedPhase 2
A Study of an Encapsulated Cell Technology (ECT) Implant for Patients With Atrophic Macular Degeneration
United States53 participantsStarted 2007-01-05
Plain-language summary
The purpose of this study is to look at the safety and effectiveness of CNTF implants on vision in participants with atrophic macular degeneration. This research is being done because there are no effective therapies for people with atrophic macular degeneration. Age-related macular degeneration (AMD) is a condition that affects the macula, the central part of the retina that we use for seeing details. There are two types of AMD, one is the wet type in which new blood vessels grow, also known as choroidal neovascularization (CNV), but the other is the dry type in which the healthy cells die, and that is the target of this study. This is called atrophic macular degeneration. The implant is a small capsule that contains human retinal pigment epithelium cells. These cells have been given the ability to make CNTF and release it through the capsule membrane into the surrounding fluid. In this study, two different CNTF dose levels will be used: a high dose and a low dose, as well as a sham surgery (or placebo) group.
Who can participate
Age range
50 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
. To participate in this study, the participant had to understand and sign the protocol's informed consent (if the participant's vision was impaired to the point where it was not possible to read the informed consent document, the informed consent document was read in its entirety to the participant).
. Women of childbearing potential (women with last menses \<1 year prior to screening) had to agree to use an effective form of birth control from study onset until they completed the 18 month study visit.
. Participant had to be medically able to undergo ophthalmic surgery for NT-501 implant.
. Best-corrected visual acuity in the study eye between 20/50 and 20/200 (68-34 letter score) as measured using EVA.
. Presence in the study and/or fellow eye of geographic atrophy (GA) compatible with category 3 or 4 age-related macular degeneration (AMD) as defined by AREDS (AREDS, 2001). Also, the GA in the study eye had to be associated with vision loss as assessed by a vision test. GA was defined as one or more well-defined, usually more or less circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appeared to be preserved and large choroidal vessels were not visible, a roundish patch of RPE partial depigmentation might still be classified as early GA. A patch had to be at least 175 microns in area.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
BCVA Response Defined as an Increased in 10 Letters at 1 Year Post-implant
. Participants had steady fixation in the study eye in the foveal or parafoveal area with media clear enough for good quality photographs.
Exclusion criteria
. Participant less than 50 years of age (to minimize geographic atrophy from causes other than AMD).
. Participant medically unable to comply with study procedures or follow-up visits.
. Participant had evidence of ocular disease other than AMD that might confound the outcome of the study (e.g., diabetic retinopathy, uveitis, etc.).
. Participant had chronic requirement (e.g., \> or = 4 weeks at a time) for ocular medications or had disease(s), that in the judgment of the examining physician, were vision threatening or might affect the primary outcome (artificial tears were permitted).
. Participant had evidence of classic or occult choroidal neovascularization in either eye, which might include serous RPE detachment, stippling on a fluorescein angiogram, macular edema, evidence of hemorrhage and lipid, and disciform scar.
. Participant had a requirement for acyclovir and/or related products during study duration. To be eligible for this study, the participant had to discontinue use of these products prior to enrollment and could not continue with the products until after they had completed the study.
. Participant had evidence of central serous chorio-retinopathy (CSR) in either eye.
. Participant had evidence of pathologic myopia in either eye.