1) To demonstrate that the FcRn functions as a transporter and protector for vitreous IgG and monoclonals (Avastin, Lucentis) and show that monoclonal therapeutic antibodies are transported over the RPE via the FcRn. 2) To investigate if…
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Confirmation of the role of FcRn in metabolism and transport of vitreous IgG
and monoclonals (Avastin, Lucentis), frequency of FcRn mutations and
polymorphisms.
Secondary outcome
NA
Background summary
IgG levels in the vitreous are used to diagnose ocular infections
(Goldmann-Witmer) and recently anti-VEGFs (Avastin, Lucentis) have been
introduced to treat neovascular age related macular degeneration (ARMD). In the
near future other immunoglobulin based biologicals will be injected in the eye.
Monoclonal anti-TNF antibodies such as Remicade and Humira are promising
candidates for local administration and also cytotoxic monoclonals like
rituximab - for treating ocular lymphomas - are to be injected locally.
However, knowledge about metabolism of IgG in the eye is scarce. Investigation
of the metabolism and transport mechanisms of these antibodies is therefore
warranted.
Mutations or polymorphisms of the FcRn gene may indicate a predisposition for
ARMD. The fact that IgG is found in drusen and in retinal pigment epithelial
(RPE) cells adjacent to drusen indicates a possible role for IgG and therefore
the neonatal Fc receptor (FcRn) in the development of ARMD.
Study objective
1) To demonstrate that the FcRn functions as a transporter and protector for
vitreous IgG and monoclonals (Avastin, Lucentis) and show that monoclonal
therapeutic antibodies are transported over the RPE via the FcRn. 2) To
investigate if polymorphisms or mutations in the FcRn gene or promoter are
related to ARMD.
Study design
1) laboratory research and 2) observational cohort study.
Study burden and risks
Participants do not benefit from this study. Risks are negligible.
Schiedamse Vest 180
3011 BH Rotterdam
NL
Schiedamse Vest 180
3011 BH Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Informed consent
- Age related macular degeneration (ARMD group) or no ARMD (control group)
Exclusion criteria
None
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL23735.078.08 |