Ranibizumab Plus Indomethacin

Università degli Studi di Brescia

Status and phase: Completed; Phase 4

Conditions: Macular Edema

Treatments: Drug: Ranibizumab Injection; Drug: Indomethacin

Study type: Interventional

Funder types: Other

Identifiers

NCT03261635

NSAIDs_02

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Ranibizumab Monotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Ranibizumab Injection

Ranibizumab + Indomethacin

Experimental group

Description:

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.

Treatment:

Drug: Indomethacin

Drug: Ranibizumab Injection