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NCT03261635 Clinical Trial

Ranibizumab Plus Indomethacin

Macular Edema Clinical Trial

Official title:
Prospective Randomized Controlled Trial of Combination Ranibizumab and Indomethacin for Exudative Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03261635
Other study ID # NSAIDs_02
Secondary ID
Status Completed
Phase Phase 4
First received August 20, 2017
Last updated August 22, 2017
Start date January 7, 2016
Est. completion date July 25, 2017

Study information
Verified date August 2017
Source Università degli Studi di Brescia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date July 25, 2017
Est. primary completion date December 7, 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ranibizumab Injection
patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata
• Indomethacin
patients self-administered one drop of indomethacin 0.5% eye drops three times a day for 12 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Università degli Studi di Brescia

Outcome
Type Measure Description Time frame Safety issue
Primary Central Retinal Thickness (microns) Optical Coherence Tomography will be used to assess central retinal thickness. 12-month
Primary Visual Acuity (LogMAR) ETDRS charts will be used to assess best corrected visual acuity 12-month
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