To assess the safety & efficacy of Fluocinolone Acetonide Intravitreal (FAI) insert in patients with Chronic, Non-Infectious Uveitis affecting the Posterior segment of the Eye

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/07/004726
• Date of registration: 10-07-2014
• Prospective Registration: Yes
• Primary sponsor: pSivida Corp
• Public title: To assess the safety & efficacy of Fluocinolone Acetonide Intravitreal (FAI) insert in patients with Chronic, Non-Infectious Uveitis affecting the Posterior segment of the Eye
• Scientific title: A Phase III, Multinational, Multiceneter, Randomized, Masked, Controlled, Safety and Efficacy study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects with Chronic Non-Infectious Uveitis affecting the Posterior Segment of the Eye
• Date of first enrolment: 08-08-2014
• Target sample size: 120
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8285
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

Germany, Hungary, India, Israel, United Kingdom, United States of America

Contacts

• Name: Dr Saurendra Das
• Affiliation: Excel Life Sciences Pvt Ltd

• Name: Dr Saurendra Das
• Affiliation: Excel Life Sciences Pvt Ltd

Key inclusion & exclusion criteria

Inclusion criteria: •Male or non-pregnant female at least 18 years of age at time of consent

• One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis > 1 year duration

• During the 12 months prior to enrollment (Day1),

the study eye has either received treatment:

• systemic corticosteroid or other systemic therapies given for at least 3 months, and/or

• at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis

OR the study eye has experienced recurrence:

• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid

• At the time of enrollment (Day 1), study eye has < 10 anterior chamber cells/HPF and a vitreous haze <= grade 2.

• Visual acuity of study eye is at least 15 letters on the ETDRS chart

• Subject is not planning to undergo elective ocular surgery during the study

• Subject has ability to understand and sign the Informed Consent Form

• Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Age eligible fo the study: 18 years & older
Exclusion criteria: • Allergy to fluocinolone acetonide or any component of the FAI insert

• History of posterior uveitis only that is not accompanied by vitritis or macular edema

• History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze

• Uveitis with infectious etiology

• Vitreous hemorrhage

• Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)

• Ocular malignancy in either eye, including choroidal melanoma

• Toxoplasmosis scar in study eye or scar related to previous viral retinitis

• Previous viral retinitis

• Media opacity precluding evaluation of retina and vitreous

• Peripheral retinal detachment in area of insertion

• Current diagnosis of any form of glaucoma

• Intraocular pressure (IOP) > 21 mmHg or concurrent therapy at Screening with any IOP-lowering agent in the study eye

• Chronic hypotony ( < 6 mmHg)

• Ocular surgery on the study eye within 3 months prior to study Day 1

• Capsulotomy in study eye within 30 days prior to study Day 1

• Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1

• Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1

• Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1

• Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1

• Subjects requiring chronic systemic or inhaled corticosteroid therapy ( >15mg prednisone daily) or systemic immunosuppressive therapy to manage non-ocular disease

• Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1

• Subjects who have tested positive for human immune deficiency virus (HIV)

• Systemic infection within 30 days prior to study Day 1

• Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study

• Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study

• Treatment with an investigational drug or device within 30 days prior to study Day 1

• Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit

• Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Chronic, Non-Infectious Uveitis affecting the Posterior Segment of the Eye Health Condition 2: H208- Other iridocyclitis

Intervention(s)

Intervention1: Fluocinolone Acetonide Intravitreal Insert: One injection, Once in 36 months, Intravitreal injection
Control Intervention1: Sham: Insert
Control Intervention2: Sham: Sham Injection, Once in 36 months, this procedure will consist of pressing the blunt end of the needle against the sclera of the eye with approximately the same pressure as would be used during the injection of a FAI insert; no ocular tissue will be penetrated

Primary Outcome(s)

Recurrence of uveitis in study eye [ Time Frame: one year ]

[ Designated as safety issue: No ]Timepoint: Time Frame: one year

Secondary Outcome(s)

Recurrence of uveitis in the study eye [ Time Frame: three years ]

[ Designated as safety issue: No ]Timepoint: Time Frame: three year

Secondary ID(s)

PSV-FAI-001 Version 3 dated March 22, 2013

Source(s) of Monetary Support

pSivida Corp

Secondary Sponsor(s)

Excel Life Sciences Pvt Ltd

Ethics review

Status: Approved
Approval date: 13/10/2016
Contact:

Ethics Committee, PBMAs H. V Desai Eye Hospital

Status: Approved
Approval date: 08/11/2016
Contact:

Ethics Committee, L.V. Prasad Eye Institute, Hyderabad

Status: Approved
Approval date: 24/12/2016
Contact:

Institutional Ethics Committee - I, KEM Hospital

Status: Approved
Approval date: 23/01/2017
Contact:

Institutional Ethics Committee Office of Research Cell King George Medical University, Lucknow

Status: Approved
Approval date: 28/01/2017
Contact:

Institutional ethics Committee,L.V.Prasad Eye Institute,Bhubaneswar

Status: Approved
Approval date: 08/03/2017
Contact:

Institutional Ethics Committee, Smt. NHL Municipal Medical College, Ahmedabad (NHLIEC)

Results

• Date Completed: 21/03/2018