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Copaxone in Age Related Macular Degeneration
Plain-language guide to NCT00466076: phase 2, phase 3 randomized trial of Glatiramer Acetate, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00466076
- Phase
- phase 2, phase 3
- Status
- status unknown
- Start
- 2006-08
- Completion (planned or actual)
- 2007-04
- Participants
- 30
- Design
- randomized, single-blind, treatment
- Conditions studied
- Macular Degeneration
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2, phase 3) is built around Glatiramer Acetate.
The registry classes the interventions as drug.
More on the Plan
The formation of insoluble extracellular deposits consisting of misfolded, aggregated protein is the hallmark of many neurodegenerative diseases.
AMD and AD are strongly correlated with advancing age and the formation of amyloid deposits.
Moreover, Ambati et al described a new model of AMD in transgenic mice when an absence of normally functioning macrophages led to the development of clinical AMD.
IL-4, reversed the impediment, attenuated TNF-a production and overcame blockage of insulin like growth factor (IGF)-I production caused by Ab.
Who Took Part
30 planned participants were the target.
It was open to people of any sex aged from 50 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Dry AMD in both eyes. Age 50 or above. Signed informed consent.
The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: known sensitivity to mannitol or copaxone; skin disease or active infection of skin; active fever or active treatment for infection.
How the Study Was Run
Design: randomized, parallel-group and single-blind.
Random assignment meant chance, not the researchers, decided who got Glatiramer Acetate and who got the comparison, which limits bias.
The Glatiramer Acetate group and the comparison group ran side by side rather than switching.
In this single-blind Glatiramer Acetate study one party knew the assignments and the other did not.
It started in 2006-08 with completion listed for 2007-04.
It ran at 1 site in Israel.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3, randomized trial of Glatiramer Acetate in 30 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Glatiramer Acetate compound page, all human trials.
Our Notes on the Compound
Glatiramer Acetate: A mix of synthetic amino-acid chains (Copaxone) used in relapsing multiple sclerosis.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.