Corticosteroid Induced Ocular Hypertension/Glaucoma Clinical Trial
Official title:
Genetic Association Study on Corticosteroid-induced Elevation of the Intraocular Pressure
| Verified date | May 2020 |
| Source | Maastricht University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Glaucoma is one of the most prevalent eye diseases and the second most common cause of
blindness worldwide. The most common form is primary open angle glaucoma (POAG). Glaucoma is
a slowly progressing neuropathy of the optic nerve that causes loss of visual field and
eventually blindness. Elevated intra-ocular pressure (IOP) is the most important risk factor.
Corticosteroids, which are often used for the treatment of many diseases in ophthalmology and
other specialities, may cause an elevation of the IOP. It is estimated that corticosteroids
induce ocular hypertension in approximately 18%-36% of the general population and in patients
with POAG this percentage can be as high as 92%. When the treatment is sustained, this can
cause a glaucomatous neuropathy of the optic nerve (corticosteroid-induced glaucoma).
The precise pathogenic mechanism isn't clear yet. Genetic factors are likely to affect the
susceptibility to corticosteroid response. Therefore, an overview of the genetic mechanisms
of corticosteroid-induced glaucoma can give more insight in the pathogenesis. In this study
the researchers investigate the occurrence of SNPs (single nucleotide polymorphisms) in 150
cases with a steroid-response in comparison with 300 controls exposed to corticosteroids
without a steroid-response.
Up to now, one small GWAS has been conducted comparing 32 patients with and without
corticosteroid-induced ocular hypertension after treatment with intravitreal triamcinolone.
In this study, two SNPs proximal of the transcriptional start site (near the 5') of HCG22 on
chromosome 6 were identified. However, this is a rather small sample population and the
investigators didn't match for the underlying disease. Further, in another small study,
Hogewind et al. performed SNP analysis in multiple genes (SFRS3, FKBP4, FKBP5, and NR3C1) in
corticosteroid-induced ocular hypertension.
This study enables the investigators to identify patients at risk for developing
corticosteroid-induced glaucoma and to gain a better insight in the pathogenesis. This may
also lead to the discovery of biomarkers that indicate an increased risk of developing a
steroid-induced glaucoma and new prevention and treatment strategies, which are necessary as
the treatment of corticosteroid induced-glaucoma now only focuses at lowering the IOP and can
still be challenging.
| Status | Completed |
| Enrollment | 370 |
| Est. completion date | May 1, 2020 |
| Est. primary completion date | February 6, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Use of corticosteroids: - Patients treated with Ozurdex (an intravitreal dexamethasone implant - Patients treated with subconjunctival Triamcinolone/ Celestone injections - Patients treated with corticosteroids after a corneal surgery - Patients treated with corticosteroids after a refractive surgery - Patients treated with corticosteroids after a cataract surgery - Patients treated with corticosteroids for macular edema - Patients exposed to corticosteroids for other diseases such as uveitis - When using topical corticosteroids, time of use > 3 months - Age > 18 year and mentally competent - Patient from the Maastricht University Medical Centre+ (MUMC+), the Netherlands Exclusion Criteria: - Age < 18 year - Mentally not able to participate or give permission - Not able to communicate in Dutch - Patients with a type of uveitis that might cause a decrease of the IOP - When using topical corticosteroids, time of use < 3 months. |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | University Eye Clinic Maastricht, Maastricht UMC+ | Maastricht | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University Medical Center |
Netherlands,
Fini ME, Schwartz SG, Gao X, Jeong S, Patel N, Itakura T, Price MO, Price FW Jr, Varma R, Stamer WD. Steroid-induced ocular hypertension/glaucoma: Focus on pharmacogenomics and implications for precision medicine. Prog Retin Eye Res. 2017 Jan;56:58-83. doi: 10.1016/j.preteyeres.2016.09.003. Epub 2016 Sep 22. Review. — View Citation
Jeong S, Patel N, Edlund CK, Hartiala J, Hazelett DJ, Itakura T, Wu PC, Avery RL, Davis JL, Flynn HW, Lalwani G, Puliafito CA, Wafapoor H, Hijikata M, Keicho N, Gao X, Argüeso P, Allayee H, Coetzee GA, Pletcher MT, Conti DV, Schwartz SG, Eaton AM, Fini ME. Identification of a Novel Mucin Gene HCG22 Associated With Steroid-Induced Ocular Hypertension. Invest Ophthalmol Vis Sci. 2015 Apr;56(4):2737-48. doi: 10.1167/iovs.14-14803. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Differences in SNP's in corticosteroid responders and non-responders | What are the differences in SNPs in patients with corticosteroid-induced ocular hypertension in comparison with patients exposed to corticosteroids who do not respond with an IOP increase | At the time of inclusion |