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

Università degli Studi di Brescia

Status and phase: Completed; Phase 4

Conditions: Wet Macular Degeneration

Treatments: Drug: Ketorolac + Ranibizumab; Drug: Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02060604

NSAIDs_01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Ketorolac + Ranibizumab

Experimental group

Description:

3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID

Treatment:

Drug: Ketorolac + Ranibizumab

Ranibizumab Alone

Active Comparator group

Description:

3 monthly ranibizumab, then as needed

Treatment:

Drug: Ranibizumab