Observational Study of CLS-TA (Triamcinolone Acetonide) for the Treatment of Macular Edema associated with Non-Infectious Uveitis

MAGNOLIA: Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema associated with Non-Infectious Uveitis - MAGNOLIA

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/08/009491

Enrollment

Registered

2017-08-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: H208- Other iridocyclitis Health Condition 2: H358- Other specified retinal disorders

Interventions

Intervention1: NAP: NAP

Eligibility

Inclusion criteria

Inclusion criteria: 1.Enrolled in the parent study , CLS1001-301, through Visit 8/Month 6 2.Willing and able to provide written informed consent prior to any study procedures; willing to comply with the instructions and attend all scheduled study visits.

Exclusion criteria

Exclusion criteria: 1.Received additional therapy for the treatment of uveitis or prohibited medication as defined in Section 6.2 of the parent protocol, CLS1001-301. 2.Require additional therapy for the treatment of uveitis or prohibited medication as defined in Section 6.2 of the parent protocol, CLS1001-301 at the time of crossover visit

Design outcomes

Primary

Measure	Time frame
To demonstrate the maintenance of efficacy of CLS-TA, up to 6 months following exit from Parent study, as shown by the need for additional therapy or the increase in maintenance therapy, for the symptoms of uveitisTimepoint: 6 months	—

Secondary

Measure	Time frame
To determine the maintenance of efficacy of CLS-TA, up to 6 months following exit from Parent study, as demonstrated by incidence of adverse events related to Parent study investigational product.Timepoint: 6 months	—

Countries

India, United States of America

Contacts

Public ContactDr Saurendra Das

Excel Life Sciences Pvt Ltd

sauren@excellifesciences.com01204022600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026