Status:
COMPLETED
Effect Aflibercept on Ocular Perfusion
Lead Sponsor:
Augenabteilung Allgemeines Krankenhaus Linz
Conditions:
Macular Degeneration
Anti Vascular Endothelial Growth Factor
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Age-related macular degeneration (AMD) is the leading cause of irreversible visual impairment in Western Countries. It is a well-established fact that vascular endothelial growth factor (VEGF) plays a...
Eligibility Criteria
Inclusion
- Men and women aged over 50 years
- written informed consent for participation in the study
- Scheduled for 3 consecutive intravitreal injections (4 week intervals) of aflibercept for treatment of exudative AMD in one eye
- Subject is generally healthy with no current significant or a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination. A significant disorder is defined as a disease or medical condition associated with impaired health status, requiring regular or current medical treatment and/or follow up. For the purposes of this study, an investigator may classify a medical condition as a nonsignificant disorder despite the fact that the subject receives treatment. Subjects having controlled Stage 1 hypertension (blood pressure of 140-159 mmHg systolic and/or 90-99 mmHg diastolic) are eligible for participation in this study.
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
Exclusion
- Active exudative AMD requiring treatment of both eyes
- Ocular surgery (including intravitreal injection) during the 3 months preceding the study
- Vitrectomized eyes
- Ametropia \> 6 Dpt
- Relevant ophthalmic diseases/conditions that could interfere with LSFG measurements (e.g. glaucoma, optic nerve head drusen, tilted disc, etc.)
- Ocular infection or clinically significant inflammation
- Opacities of the cornea (e.g. corneal scars, corneal oedema), the lens (e.g. LOCS-II grading \> 2, posterior capsule opacification) or the vitreous (e.g. vitreous haemorrhage, asteroid hyalosis)
- Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus)
- Blood donation in the 3 weeks preceding the study
- Participation in a clinical trial in the 3 weeks preceding the study
- Pre- or perimenopausal women
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03804099
Start Date
March 1 2017
End Date
May 18 2018
Last Update
January 15 2019
Active Locations (1)
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1
Department of Ophthalmology, Kepler University Hospital
Linz, Austria, 4020