A research to study the effect of Fluocinolone Acetonide Intravitreal (FAI) Insert in Patients with inflammation of middle layer of the eye
- Conditions
- Health Condition 1: null- Chronic Non Infectious Uveitis Affecting the Posterior Segment of the eyeHealth Condition 2: H208- Other iridocyclitis
- Registration Number
- CTRI/2014/12/005337
- Lead Sponsor
- pSivida Corp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 150
1.Male or non-pregnant female at least 18 years of age at time of consent
2.One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis greater than or equal to 1 year duration
3.During the 12 months prior to enrollment (Day1), either the study eye has received treatment:
a.systemic corticosteroid or other systemic therapies given for at least 3 months, and/or
b.at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis
OR the study eye has experienced recurrence:
c.at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid
4.At the time of enrollment (Day 1), study eye has less than 10 anterior chamber cells/HPF and a vitreous haze less than or equal to grade 2.
5.Visual acuity of study eye is at least 15 letters on the ETDRS chart
6.Subject is not planning to undergo elective ocular surgery during the study
7.Subject has ability to understand and sign the Informed Consent Form
8.Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
1.Allergy to fluocinolone acetonide or any component of the FAI insert
2.History of posterior uveitis only that is not accompanied by vitritis or macular edema
3.History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze
4.Uveitis with infectious etiology
5.Vitreous hemorrhage
6.Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)
7.Ocular malignancy in either eye, including choroidal melanoma
8.Toxoplasmosis scar in study eye or scar related to previous viral retinitis
9.Previous viral retinitis
10.Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures
11.Media opacity precluding evaluation of retina and vitreous
12.Peripheral retinal detachment in area of insertion
13.Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-21 mmHg)
14.Intraocular pressure (IOP) greater than 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye
15.Chronic hypotony (less than 6 mmHg)
16.Ocular surgery on the study eye within 3 months prior to study Day 1
17.Capsulotomy in study eye within 30 days prior to study Day 1
18.Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1
19.Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1
20.Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1
21.Peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1
22.Subjects requiring chronic systemic or inhaled corticosteroid therapy (greater than 15mg prednisone daily) or chronic systemic immunosuppressive therapy
23.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
24.Subjects who yield, during screening, a confirmed positive test for human immune deficiency virus (HIV), syphilis or subjects with mycobacterial uveitis or chorio-retinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis.
25.Systemic infection within 30 days prior to study Day 1
26.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
27.Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study
28.Treatment with an investigational drug or device within 30 days prior to study Day 1
29.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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method