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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Soll Eye
Study ID
NCT02294656
Phase
PHASE1
Status
Completed

Conditions

  • CYSTOID MACULAR EDEMA

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Nov 19, 2014
Start date
Nov 30, 2014
Status verified
Sep 2018
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018

Study Design

Enrollment
4 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Soll EyePhiladelphiaPennsylvania19116-

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