Ranibizumab Plus Indomethacin

Sponsor
Università degli Studi di Brescia
Study ID
NCT03261635
Phase
PHASE4
Status
Completed

Conditions

  • Macular Edema

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Aug 25, 2017
Start date
Jan 7, 2016
Status verified
Aug 2017
Primary completion
Dec 7, 2016
Completion
Jul 25, 2017

Study Design

Enrollment
58 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ranibizumab Monotherapy
    All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata
  • Experimental: Ranibizumab + Indomethacin
    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.

Primary Outcome Measure

Central Retinal Thickness (microns) [ Time Frame: 12-month ]

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