Ranibizumab Plus Indomethacin

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03261635

Enrollment

Registered

2017-08-25

Start date

2016-01-07

Completion date

2017-07-25

Last updated

2017-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema

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.

Interventions

DRUGRanibizumab Injection

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

DRUGIndomethacin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026