Effect of Simvastatin Withdrawal on Ocular Endothelial Function

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02533141
• Date of registration: 24/08/2015
• Prospective Registration: Yes
• Primary sponsor: Medical University of Vienna
• Public title: Effect of Simvastatin Withdrawal on Ocular Endothelial Function
• Scientific title: Effect of Simvastatin Withdrawal on Ocular Endothelial Function
• Date of first enrolment: October 2019
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02533141
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion Criteria:

Informed consent for participation

- Men and women aged between 18 and 45 years, non-smokers

- Body mass index between 15th and 85th percentile

- Normal findings in the medical history and physical examination unless the
investigator considers an abnormality to be clinically irrelevant

- Normal laboratory values unless the investigator considers an abnormality to be
clinically irrelevant

- Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg

- Normal ophthalmic findings, ametropia less than 6 diopters

Exclusion Criteria:

- History or presence of ocular disease

- Ametropy = 6 dpt

- Previous or current treatment with statins

- Treatment with any drug in the 3 weeks preceding the first study day

- Symptoms of a clinically relevant illness in the 3 weeks before the first study day

- Participation in a clinical trial in the 3 weeks preceding the first study day

- Blood donation during the 3 weeks preceding the first study day

- History or family history of epilepsy

- History or presence of myopathy, renal failure or elevation of creatine kinase (CK)
above normal levels

- History or presence of hepatic dysfunction, including increase of liver enzymes

- Abuse of alcoholic beverages

- Pregnancy



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Simvastatin

Device: Dynamic Vessel Analyzer (DVA)

Device: Laser Doppler Velocimetry (LDV)

Other: Placebo

Primary Outcome(s)

Flicker induced vasodilatation (DVA) [Time Frame: 16 weeks]

Secondary Outcome(s)

Retinal oxygen saturation (DVA) [Time Frame: 16 weeks]

Red blood cell velocity (LDV) [Time Frame: 16 weeks]

Secondary ID(s)

OPHT-240215

Source(s) of Monetary Support

Please refer to primary and secondary sponsors