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.