Overview

Pilot Study of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
All
Summary
The addition of an anti-inflammatory agent could be a valid option for controlling choroidal neovascularization, as simply inhibiting VEGF addresses neither the multifactorial pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Università degli Studi di Brescia
Treatments:
Ketorolac
Ketorolac Tromethamine
Ophthalmic Solutions
Ranibizumab
Tetrahydrozoline
Criteria
Inclusion Criteria:

1. ability to provide written informed consent and comply with study assessments for the
full duration of the study;

2. age >40 years;

3. presence of treatment-naïve neovascular AMD with a visual acuity between 20/25 and
20/200 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Inclusion
criteria for AMD were neovascularisation, fluid, or haemorrhage under the fovea.

Exclusion Criteria:

1. any previous intravitreal treatment;

2. previous laser treatment in the study eye;

3. myopia >7 dioptres in the study eye;

4. concurrent eye disease in the study eye that could compromise visual acuity (eg,
diabetic retinopathy, advanced glaucoma);

5. concurrent corneal epithelial disruption or any condition that would affect the
ability of the cornea to heal;

6. known sensitivity to any component of the formulations under investigation.