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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02060604

Enrollment

Registered

2014-02-12

Start date

2012-12-31

Completion date

2014-01-31

Last updated

2014-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Macular Degeneration

Keywords

ketorolac, NSAIDs, wet macular degeneration, choroidal neovascularization

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.

Interventions

DRUGKetorolac + Ranibizumab

3 monthly ranibizumab, then as needed Ketorolac TID

DRUGRanibizumab

3 monthly ranibizumab, then as needed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026