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

NCT02294656 | Completed Phase 1

• 1 other identifier: ML27905
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CYSTOID MACULAR EDEMA

Keywords

CYSTOID MACULAR EDEMA

Outcome Measures

Primary Outcomes (1)

• SAFETY of INTRAVITREAL RANIBIZUMAB VS. TRIAMCINOLONE ACETONIDE FOR ACUTE PSEUDOPHAKIC CYSTOID MACULAR EDEMA TREATMENT (Incidence and severity of ocular adverse events)

  To assess the safety of intravitreal R and T for the treatment of acute pseudophakic cystoid macular edema by evaluating: * Incidence and severity of ocular adverse events, as identified by eye examination * Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs

  12 Months

Secondary Outcomes (6)

• Mean change in spectral domain OCT CMT from baseline (microns)

  12 Months

• Mean change in ETDRS letters from baseline (letters)

  12 Months

• Proportion of patients with 3 line or better ETDRS letter improvement (%)

  12 Months

• Time to 3 line ETDRS letter improvement (days)

  12 Months

• Mean number of R or T injections (#)

  12 Months

Study Arms (2)

RANIBIZUMAB

EXPERIMENTAL

Ranibizumab patients will receive three monthly Ranibizumab 0.5 mg/0.05 mL injections, followed by PRN dosing, as treatment for acute pseudophakic cystoid macular edema.

Drug: Ranibizumab,

TRIAMCINOLONE ACETONIDE

ACTIVE COMPARATOR

Triamcinolone acetonide patients will receive PRN Triamcinolone acetonide 4 mg/0.1 mL injections, every 3 months, as treatment for acute pseudophakic cystoid macular edema.

Drug: Triamcinolone acetonide

Interventions

Ranibizumab, DRUG

Intravitreal injection of Ranibizumab as treatment for acute pseudophakic cystoid macular edema. Ranibizumab patients will receive three monthly Ranibizumab 0.5 mg/0.05 mL injections, followed by PRN dosing, as treatment for acute pseudophakic cystoid macular edema.

Also known as: Lucentis

RANIBIZUMAB

Triamcinolone acetonide DRUG

Intravitreal injection of Triamcinolone acetonide as treatment for acute pseudophakic cystoid macular edema. Triamcinolone acetonide patients will receive PRN Triamcinolone acetonide 4 mg/0.1 mL injections, every 3 months, as treatment for acute pseudophakic cystoid macular edema.

Also known as: Triesence

TRIAMCINOLONE ACETONIDE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Soll Eye: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Soll Eye

Philadelphia, Pennsylvania, 19116, United States

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab; Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• DAVID RHO, MD

  Soll Eye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 19, 2014
• Study Start: November 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)