EVALUATION OF THE EFFICACY AND SAFETY OF A NEW STEROID-ANTIBIOTIC OPHTHALMIC GEL AS ANTI-INFLAMMATORY AND ANTIMICROBIAL TOPICAL TREATMENT FOLLOWING MICROINCISIONAL VITREO-RETINAL SURGERY. - ND

• Conditions: Ocular inflammation following microincisional vitreo-retinal surgery; MedDRA version: 9.1Level: LLTClassification code 10054364Term: Conjunctival hyperemia

• Registration Number: EUCTR2008-005082-64-IT
• Lead Sponsor: SIFI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Subjects showing epiretinal macular membranes and having to undergo sutureless 23-25 gauge vitreoretinal surgery; 2.Able and willing to give informed consent; 3.Age between 30-70 years; 4.Any race and sex; 5.Willing and able to attend required study visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Recurrent anterior or posterior segment inflammation of unknown aetiology or history of inflammation and/or ocular trauma in the affected eye during the last 12 months; 2.Concomitant systemic and ocular pathologies (diabetes, ocular infections, glaucoma, ocular hypertension, severe dry-eye); 3.Patients having to undergo a combined vitreo-retinal and cataract extraction surgery; 4.Patients who underwent preceding vitreo-retinal surgeries adopting a buckling procedure; 5.Patients who underwent preceding laser or cryotherapy retinopexi; 6.Cataract surgery in the affected eye within 3 months before the beginning of the study; 7.Ocular surgery in the affected eye, other than cataract extraction, within 12 months before the beginning of the study; 8.Intraocular pressure >22 mmHg; 9.Intake of any pharmaceutical form of antibiotics, antihistamines, decongestants, steroids or non-steroidal anti-inflammatory agents within 14 days prior to study entry 10.Use of ocular medication other than artificial tears; 11.Known or suspected allergy to ocular preservatives, aminoglycosides and steroids; 12.Subjects currently participating in another clinical study or who have participated in a clinical study in the preceding 30 days; 13.Pregnant or nursing women or inadequate birth control methods (applicable to female of childbearing potential only); 14.Monophthalmic. Moreover, the following intra-operative exclusion criteria will be considered: 1.Intra-vitreal administration of triamcinolone acetonide; 2.Use of tamponating gas; 3.Need for suture.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified