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

NCT02060604 | Completed Phase 4

• 1 other identifier: NSAIDs_01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Wet Macular Degeneration

Keywords

ketorolac; NSAIDs; wet macular degeneration; choroidal neovascularization

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Ketorolac + Ranibizumab

EXPERIMENTAL

3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID

Drug: Ketorolac + Ranibizumab

Ranibizumab Alone

ACTIVE COMPARATOR

3 monthly ranibizumab, then as needed

Drug: Ranibizumab

Interventions

Ketorolac + Ranibizumab DRUG

3 monthly ranibizumab, then as needed Ketorolac TID

Ketorolac + Ranibizumab

Ranibizumab DRUG

3 monthly ranibizumab, then as needed

Ranibizumab Alone

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (1)

Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

MeSH Terms

Conditions

Wet Macular Degeneration; Choroidal Neovascularization

Interventions

Ketorolac; Ranibizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Andrea Russo, MD

  University of Brescia, Italy

  PRINCIPAL INVESTIGATOR

• Luisa Delcassi, MD

  University of Brescia, Italy

  STUDY CHAIR

• Francesco Semeraro, Professor

  University of Brescia, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 8, 2014
• First Posted: February 12, 2014
• Study Start: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

IT (1)