EUCTR2016-004608-78-AT
Active, not recruiting
Phase 1
The Effect of Intravitreal Aflibercept on Ocular Perfusion – a Pilot Study
Kepler University Hospital, Institute of Ophthalmology0 sitesJanuary 23, 2017
ConditionsExudative AMDMedDRA version: 19.1Level: LLTClassification code 10025411Term: Macular degeneration senileSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsEylea
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Exudative AMD
- Sponsor
- Kepler University Hospital, Institute of Ophthalmology
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Men and women aged over 50 years
- •\- If patient is a woman – post\-menopausal (final menstruation period at least 3 years before Screening visit)
- •\- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 10
Exclusion Criteria
- •\- Active exudative AMD requiring treatment of both eyes
- •\- Ocular surgery (including intravitreal injection) during the 3 months preceding the study
- •\- Vitrectomized eyes
- •\- History of diabetes
- •\- 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
Outcomes
Primary Outcomes
Not specified
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