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

Wet Macular Degeneration Clinical Trial

Official title:

A Randomised Controlled Trial of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060604
• Other study ID #: NSAIDs_01
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2014
• Last updated: February 8, 2014
• Start date: December 2012
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Sistema Sanitario Nazionale
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Ketorolac + Ranibizumab
3 monthly ranibizumab, then as needed Ketorolac TID
• Ranibizumab
3 monthly ranibizumab, then as needed

Locations

Country	Name	City	State
Italy	Spedali Civili di Brescia	Brescia	BS

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score		12 months	No
Secondary	mean change in central macular thickness		12 months	No
Secondary	mean number of intravitreal injections over the 12-month period		12 months	No
Secondary	adverse ocular events at 12 months		12 months	Yes