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OpenTrials
Completed

NCT Number: NCT02060604

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

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.

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Key information

Conditions

Wet Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ability to provide written informed consent and comply with study assessments for the full duration of the study;
  • age >40 years;
  • 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

  • any previous intravitreal treatment;
  • previous laser treatment in the study eye;
  • myopia >7 dioptres in the study eye;
  • concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma);
  • concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal;
  • known sensitivity to any component of the formulations under investigation.

Treatment and study plan

Ketorolac + Ranibizumab

Drug

3 monthly ranibizumab, then as needed Ketorolac TID

ranibizumab

Drug

3 monthly ranibizumab, then as needed

Primary outcomes

  1. mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score

    Time frame: 12 months

Secondary outcomes

  1. mean change in central macular thickness

    Time frame: 12 months

  2. mean number of intravitreal injections over the 12-month period

    Time frame: 12 months

  3. adverse ocular events at 12 months

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2014
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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