Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, Phase I/II study evaluating intravitreal ranibizumab (R) vs. intravitreal Triesence (triamcinolone acetonide) (T) in subjects with acute pseudophakic cystoid macular edema (CME). Twenty consented patients with acute CME after phacoemulsification cataract surgery with posterior chamber intraocular lens implantation (PE/PCIOL) will be randomized 1:1 to treatment with R or T. R patients will receive three monthly R injections, followed by PRN dosing. T patients will receive PRN injections every 3 months. Clinical CME is defined as clinically evident CME, with visual acuity (VA) typically in the 20/40 to 20/200 range. Re-treatment criteria will include clinically evident worsening of CME, combined with any of the following:

• Any increase in spectral domain ocular coherence tomography (OCT) central macular thickness (CMT)

• Any observable fluid on OCT

• Any qualitatively increased perifoveal leakage/pooling on fluorescein angiography (FA).

Patients will be followed monthly through 12 months.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Soll Eye
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Age > 18 years

• Treatment naive subjects with a history of uncomplicated cataract surgery within 3 months of referral for treatment and a diagnosis of CME secondary to cataract surgery within 1 month of referral for treatment.

• Best corrected ETDRS VA of 20/40 - 20/400.

• Spectral domain OCT central retinal thickness > 300 microns.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

• Any prior treatment for CME secondary to cataract surgery including but not limited to pre or post-operative corticosteroids, NSAIDS, etc.

• Subject has significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy

• Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, etc.

• History of allergy to fluorescein, not amenable to treatment

• History of glaucoma surgery

• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

• Concurrent use of systemic anti-VEGF agents

• Have received any other systemic experimental drug within 12 weeks prior to enrollment.

• Currently being treated for active systemic infection

• Inability to comply with study or follow-up procedures.

• Patient has a condition that, in the opinion of the investigator would preclude participation in the study (i.e. chronic alcoholism, drug abuse)

• Pregnancy (positive pregnancy test) or lactation

• Pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

• Participation in another simultaneous medical investigation or trial