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Effect Aflibercept on Ocular Perfusion

Primary Purpose

Macular Degeneration, Anti Vascular Endothelial Growth Factor

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Aflibercept Injection [Eylea]
Sponsored by
Augenabteilung Allgemeines Krankenhaus Linz
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Department of Ophthalmology, Kepler University Hospital

Outcomes

Primary Outcome Measures

Mean blur ratio (LSFG)
Quantitative parameter of red blood cells velocity

Secondary Outcome Measures

Full Information

First Posted
June 29, 2018
Last Updated
January 14, 2019
Sponsor
Augenabteilung Allgemeines Krankenhaus Linz
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1. Study Identification

Unique Protocol Identification Number
NCT03804099
Brief Title
Effect Aflibercept on Ocular Perfusion
Official Title
The Effect of Intravitreal Aflibercept on Ocular Perfusion - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
May 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augenabteilung Allgemeines Krankenhaus Linz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 key part in the development of the neovascular (or exsudative) form of AMD. Today, VEGF-inhibition by means of injection of anti-VEGF agents into the vitreous cavity constitutes the gold standard of AMD therapy. In physiological conditions, VEGF acts as a vasodilator by activating endothelial nitric oxide synthase. As a consequence, VEGF inhibition should result in significant ocular vasoconstriction, which has in fact been demonstrated for bevacizumab and ranibizumab, two of the three available VEGF-inhibitors. The understanding and awareness of potentially harmful implications of the induced vasoconstriction on retinal and/or optic nerve head structure and function is sparse. This is especially delicate, as most patients with exsudative AMD require repeated injections on a monthly basis for many years. Aflibercept, the latest anti-VEGF agent approved for intravitreal use in 2011, offers a superior binding affinity for VEGF compared to the former two drugs. However, as of today, its effect on ocular circulation is unclear. With Laser Speckle Flowgraphy (LSFG), a commercially available, non-invasive and patient-friendly method for the evaluation of blood flow at the optic nerve head, the choroid and retina has arisen in recent years. We aim to measure ocular perfusion with LSFG before and after 3 consecutive injections of aflibercept in unilateral neovascular age-related maculopathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Anti Vascular Endothelial Growth Factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aflibercept Injection [Eylea]
Intervention Description
After instillation of topical anesthetic, sterilization of the eyelid, and instillation of 1.25% povidone-iodine drops, 2.0 mg/0.05 mL of aflibercept (Eylea) is injected into the vitreous cavity through a standard pars plana approach (3.5 mm posterior to the limbus) under sterile conditions
Primary Outcome Measure Information:
Title
Mean blur ratio (LSFG)
Description
Quantitative parameter of red blood cells velocity
Time Frame
Baseline, 1 week (at the time point of injection 2 and 3), 1 month after injection 3

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Facility Information:
Facility Name
Department of Ophthalmology, Kepler University Hospital
City
Linz
ZIP/Postal Code
4020
Country
Austria

12. IPD Sharing Statement

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Effect Aflibercept on Ocular Perfusion

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