Research with human participants

Overview of medical research in the Netherlands

Destructive inflammatory reaction after an autologous retinal pigment epithelium and choroid transplantation

Published:
Last updated:

Development of a laboratory assay

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Retina, choroid and vitreous haemorrhages and vascular disorders
Study type
Observational invasive

ID

NL-OMON49580

Source

ToetsingOnline

Brief title

Rejection-like reaction RPE-choroid graft

Condition

  • Retina, choroid and vitreous haemorrhages and vascular disorders

Synonym

Rejection-like reaction RPE-choroid graft

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
Combined Opthalmic Research Rotterdam

Intervention

Keyword :
autologous graft, rejection reaction, RPE-choroid

Outcome measures

Primary outcome

The presence or absence of anti-RPE and anti-choroid auto-antibodies

Secondary outcome

HLA haplotype

Genotype analyse om polymorphismen gerelateerd aan immunologische mechanismen

aan te tonen. Complement activatie

Background summary

5 patients developed a rejection-like reaction after an autologous
transplantation of retinal pigment epithelium (RPE) and choroid for exudative
age-related macular degeneration (AMD). Surgically damaged tissue may have
elicited an inflammatory destructive reaction, either auto-immune or aspecific.

Study objective

Development of a laboratory assay

Study design

Case-control study

Study burden and risks

Participants do not benefit, risks are negligible, burden is low.

Public
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL
Scientific
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Age * 18 years
Informed consent

Exclusion criteria

A history of diabetic retinopathy, uveitis, or systemic auto-immune disease

Design

Study type :
Observational invasive
Intervention model
:
Other
Allocation :
Non-randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Basic science

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
18
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

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 NL72704.078.20