Human Vitreous Concentration of Brimonidine after Instillation of Ailamide Combination Ophthalmic Suspensio

Not Applicable

• Conditions: Idiopathic epiretinal membrane, macular hole

• Registration Number: JPRN-jRCTs051200089
• Lead Sponsor: Inatani Masaru

Brief Summary

The brimonidine concentration in the vitreous following topical application of Ailamide was above the effective concentration of neuroprotection in humans. Ailamide achieved brimonidine distribution in the aqueous humor that was comparable to that for the single-drug formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-25
• Study Completion: 2021-06-18
• Results First Posted: 2023-06-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1)Patients with written informed consent obtained after adequate explanation on participating the study
2)Male or female,20 years of age or older
3)Patients who undergo vitrectomy for idiopathic epiretinal membrane or macular hole

Exclusion Criteria

1)Patients with ocular inflammation
2)Patients with vitreous hemorrhage
3)Patients with proliferative diabetic retinopathy
4)Patients with severe corneal epithelium disorder
5)Patients with contraindications or patients in whom precautions are required for the use of Brimonidine/ Brinzolamide fixed combination.
6)Patients with a history of serious side effects against alpha 2-adrenergic receptor agonist or carbonic anhydrase inhibitor
7)Women who are pregnant, lactating or may be pregnant, or planning to be pregnant during the study period, or can not agree to contraception
8)Patients who have been considered inappropriate as study subjects by doctor

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of brimonidine in the aqueous humor and vitreous

Secondary Outcome Measures

Name	Time	Method
Concentration of brinzolamide in the aqueous humor and vitreous, Correlation between concentration of drugs in the aqueous humor and vitreous and patient background , ocular fundus (blood vessel), adverse events, visual acuity, intraocular pressure, ophthalmologic findings (cornea, conjunctiva)