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

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ClinicalTrials.gov Identifier: NCT02294656
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Soll Eye

Study Description
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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.


Condition or disease Intervention/treatment Phase
CYSTOID MACULAR EDEMA Drug: Ranibizumab, Drug: Triamcinolone acetonide Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide
Actual Study Start Date : November 2014
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: RANIBIZUMAB
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,
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.
Other Name: Lucentis
Active Comparator: TRIAMCINOLONE ACETONIDE
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
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.
Other Name: Triesence


Outcome Measures
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Primary Outcome Measures :
  1. SAFETY of INTRAVITREAL RANIBIZUMAB VS. TRIAMCINOLONE ACETONIDE FOR ACUTE PSEUDOPHAKIC CYSTOID MACULAR EDEMA TREATMENT (Incidence and severity of ocular adverse events) [ Time Frame: 12 Months ]

    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


Secondary Outcome Measures :
  1. Mean change in spectral domain OCT CMT from baseline (microns) [ Time Frame: 12 Months ]
    Mean change in spectral domain OCT CMT from baseline (microns)

  2. Mean change in ETDRS letters from baseline (letters) [ Time Frame: 12 Months ]
    Mean change in ETDRS letters from baseline (letters)

  3. Proportion of patients with 3 line or better ETDRS letter improvement (%) [ Time Frame: 12 Months ]
    Proportion of patients with 3 line or better ETDRS letter improvement (%)

  4. Time to 3 line ETDRS letter improvement (days) [ Time Frame: 12 Months ]
    Time to 3 line ETDRS letter improvement (days)

  5. Mean number of R or T injections (#) [ Time Frame: 12 Months ]
    Mean number of R or T injections (#)

  6. Mean IOP (mm Hg) [ Time Frame: 12 Months ]
    Mean IOP (mm Hg)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294656


Locations
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United States, Pennsylvania
Soll Eye
Philadelphia, Pennsylvania, United States, 19116
Sponsors and Collaborators
Soll Eye
Genentech, Inc.
Investigators
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Principal Investigator: DAVID RHO, MD Soll Eye
More Information
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Responsible Party: Soll Eye
ClinicalTrials.gov Identifier: NCT02294656     History of Changes
Other Study ID Numbers: ML27905
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Soll Eye:
CYSTOID MACULAR EDEMA
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Ranibizumab
Triamcinolone diacetate
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action