Ranibizumab Plus Indomethacin

NCT03261635 | Completed Phase 4

• 1 other identifier: NSAIDs_02
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV) in age-related macular degeneration.

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (2)

• Central Retinal Thickness (microns)

  Optical Coherence Tomography will be used to assess central retinal thickness.

  12-month

• Visual Acuity (LogMAR)

  ETDRS charts will be used to assess best corrected visual acuity

  12-month

Study Arms (2)

Ranibizumab Monotherapy

ACTIVE COMPARATOR

All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata

Drug: Ranibizumab Injection

Ranibizumab + Indomethacin

EXPERIMENTAL

All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.

Drug: Ranibizumab Injection; Drug: Indomethacin

Interventions

Ranibizumab Injection DRUG

patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata

Ranibizumab + Indomethacin; Ranibizumab Monotherapy

Indomethacin DRUG

patients self-administered one drop of indomethacin 0.5% eye drops three times a day for 12 months

Ranibizumab + Indomethacin

Eligibility Criteria

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

You may qualify if:

• provision of written informed consent and compliance with study assessments for the full duration of the study
• age \> 40 years
• presence of treatment-naïve neovascular AMD.

You may not qualify if:

• any previous intravitreal treatment
• previous laser treatment in the study eye
• myopia \> 7 diopters in the study eye
• concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and 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 being investigated.

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab; Indomethacin

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

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: Principal Investigator

Model Details: This was a prospective, randomized, pilot study in 58 patients with naï ve CNV. Patients were randomized 1:1 into 2 groups: ranibizumab monotherapy (RM group) and ranibizumab plus indomethacin (RI group). All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. RI patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: August 25, 2017
• Study Start: January 7, 2016
• Primary Completion: December 7, 2016
• Study Completion: July 25, 2017
• Last Updated: August 25, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share