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

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ClinicalTrials.gov Identifier: NCT02060604
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
Andrea Russo, 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.

Condition or disease Intervention/treatment Phase
Wet Macular Degeneration Drug: Ketorolac + Ranibizumab Drug: Ranibizumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration
Study Start Date : December 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketorolac + Ranibizumab
3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID
Drug: Ketorolac + Ranibizumab
3 monthly ranibizumab, then as needed Ketorolac TID

Active Comparator: Ranibizumab Alone
3 monthly ranibizumab, then as needed
Drug: Ranibizumab
3 monthly ranibizumab, then as needed




Primary Outcome Measures :
  1. mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060604


Locations
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Italy
Spedali Civili di Brescia
Brescia, BS, Italy, 25123
Sponsors and Collaborators
Università degli Studi di Brescia
Investigators
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Principal Investigator: Andrea Russo, MD University of Brescia, Italy
Study Chair: Luisa Delcassi, MD University of Brescia, Italy
Study Director: Francesco Semeraro, Professor University of Brescia, Italy

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Responsible Party: Andrea Russo, MD, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT02060604     History of Changes
Other Study ID Numbers: NSAIDs_01
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Keywords provided by Andrea Russo, Università degli Studi di Brescia:
ketorolac
NSAIDs
wet macular degeneration
choroidal neovascularization

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Ophthalmic Solutions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions