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CompletedNCT01997489Updated Oct 28, 2014

Ophthalmic Findings During 10-year Enzyme Substitution of Danish Fabry Patients.

A Phase 4 interventional study of Enzyme replacement in Fabry Disease, sponsored by Rigshospitalet, Denmark. Completed at 2 sites in Denmark. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2014-10-28.

Sponsored by Rigshospitalet, Denmark · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
15 Years and older
Sex
All
01

Study summary

Fabry disease is a recessively inherited disorder due to systemic storage of abnormal metabolites (ceramide trihexocide, in particular) caused by lack of the lysosomal enzyme α-galactosidase. Though X-linked, in patient series there are often equal numbers of males (hemizygotes ) and females (heterozygotes, probably caused by a mutation in one allele and an inactivation on the other allele in the X chromosomes), and many clinical features are shared.

Abnormal storage in endothelial and smooth muscle cells explains morbidity, including a shortened life expectancy. This is due to age dependent ischaemic manifestations that affect heart, kidney and brain. Angiofibroma is an early cutaneous manifestation, and painful acro-paresthesias express juvenile neuropathy.

Cornea verticillata is an almost obligate ophthalmic finding. The brown-yellow Bowman membrane related corneal deposits and teleangiectatic conjunctival vessels are early ophthalmic slit-lamp markers of the disorder; further there can be subtle lens opacities. Fundus vessel tortuosity is observed in many patients, in particular of the retinal venules, but best corrected visual acuity (BCVA) is usually normal.

After the introduction of enzyme substitution therapy in 2001, ophthalmic examinations were scheduled as regular part of the general evaluation of the Fabry patients at Rigshospitalet, Denmark. A 10-year ophthalmic state of arts was part of oral presentations at a Copenhagen conference in December 2011. In contrast to the common occurrence of systemic vascular sequels, only one patient in the series had suffered severe visual loss; this was unilateral and occurred years before institution of the enzyme therapy. In 2013, however, another young male presented a similar retinal event. Sporadic cases of visual loss are reported in the literature, but in larger Fabry series ocular vascular catastrophes appear the exception to the rule.

Following the introduction of enzyme substitution, we found it of interest to present our nationwide Danish experience. We focused on retinal vessel morphology and the relation to systemic morbidity.

Read the detailed description

Fabry disease is a recessively inherited disorder due to systemic storage of abnormal metabolites (ceramide trihexocide, in particular) caused by lack of the lysosomal enzyme α-galactosidase. Though X-linked, in patient series there are often equal numbers of males (hemizygotes ) and females (heterozygotes, probably caused by a mutation in one allele and an inactivation on the other allele in the X chromosomes), and many clinical features are shared (Cox 2005).

Abnormal storage in endothelial and smooth muscle cells explains morbidity, including a shortened life expectancy (Frost \& Tanaka 1966; Desnick et al. 1976; deVeber et al.1992; Hughes \& Mehta 2005; Nguyen et al. 2005; Sodi et al. 2007). This is due to age dependent ischaemic manifestations that affect heart, kidney and brain. Angiofibroma is an early cutaneous manifestation, and painful acro-paresthesias express juvenile neuropathy (Cox 2005; Cleary et al. 2005).

Cornea verticillata is an almost obligate ophthalmic finding. The brown-yellow Bowman membrane related corneal deposits and teleangiectatic conjunctival vessels are early ophthalmic slit-lamp markers of the disorder; further there can be subtle lens opacities. Fundus vessel tortuosity is observed in many patients, in particular of the retinal venules, but best corrected visual acuity (BCVA) is usually normal (Ballantyne \& Michaelson 1970; Lou et al. 1970; Sher et al. 1979; Utsumi et al. 2009).

After the introduction of enzyme substitution therapy in 2001, ophthalmic examinations were scheduled as regular part of the general evaluation of the Fabry patients at Rigshospitalet, Denmark. A 10-year ophthalmic state of arts was part of oral presentations at a Copenhagen conference in December 2011. In contrast to the common occurrence of systemic vascular sequels, only one patient in the series had suffered severe visual loss; this was unilateral and occurred years before institution of the enzyme therapy (Andersen et al. 1994). In 2013, however, another young male presented a similar retinal event. Sporadic cases of visual loss are reported in the literature (Sher et al. 1978,1979; Tuupurainen et al. 1981; Sakkuraba et al. 1986; Utsumi et al. 2009), but in larger Fabry series ocular vascular catastrophes appear the exception to the rule (Orssaud et al. 2003; Hughes \& Mehta 2005; Nguyen et al. 2005; Sodi et al. 2007; Utsumi et al. 2009)).

Following the introduction of enzyme substitution, we found it of interest to present our nationwide Danish experience. We focused on retinal vessel morphology and the relation to systemic morbidity.

02

Conditions studied

  • Fabry Disease

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Keywords

  • Eye
  • Fabry
  • vessels
03

In context

Fabry Disease

242 studies on the registry are indexed under Fabry Disease; 54 are open to participants now.

This study's enrollment of 39 is above the median of 22 across 105 interventional studies indexed under Fabry Disease.

Browse Fabry Disease studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All Danish patients with Fabry disease before starting therapy

Exclusion criteria

Exclusion Criteria:

  • Missing values for eye examination at baseline or follow-up
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Fabry patients during treatment

    39 patients with Fabry disease having had baseline examinations of the eyes were assessed also at follow-up 10 years after enzyme replacement therapy

    Drug: Enzyme replacement

Interventions

  • DrugEnzyme replacement

    Observational study of current treatment and with no comparative groups

    Also known as: Replagal, Fabrazyme

06

What researchers measure

Primary outcomes

  1. cornea vercillitata

    Eye examination of 39 Fabry patients before starting therapy with enzyme replacement and after 10 years

    Time frame: change from baseline to 10 years

07

Study locations

2 sites
  • Ulla Feldt-Rasmussen
    Copenhagen, Capital region DK-2100, Denmark
  • National University Hospital, Department of Medical Endocrinology
    Copenhagen, DK-2100, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01997489
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Ulla Feldt-Rasmussen (Professor, chief physician, Rigshospitalet, Denmark) — Principal investigator
First posted
Nov 28, 2013
Start date
Sep 2001
Primary completion
Sep 2013
Completion
Oct 2014
Last update
Oct 28, 2014

Study contacts

Ulla Feldt-Rasmussen, MD, DMSc
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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