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

Phase 4

Completed

• Conditions: Wet Macular Degeneration
• Interventions: Drug: Ketorolac + Ranibizumab; Drug: Ranibizumab

• Registration Number: NCT02060604
• Lead Sponsor: Università degli Studi di Brescia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-02
• Study First Submitted: 2014-02-08
• Study First Submitted QC: 2014-02-08
• Last Update Submitted: 2014-02-08
• Study First Posted: 2014-02-12
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac + Ranibizumab	Ketorolac + Ranibizumab	3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID
Ranibizumab Alone	Ranibizumab	3 monthly ranibizumab, then as needed

Primary Outcome Measures

Name	Time	Method
mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score	12 months

Secondary Outcome Measures

Name	Time	Method
mean change in central macular thickness	12 months
mean number of intravitreal injections over the 12-month period	12 months
adverse ocular events at 12 months	12 months

Trial Locations

Locations (1)

Spedali Civili di Brescia; 🇮🇹 Brescia, BS, Italy