Combined Therapy in Age-Related Macular Degeneration (ARMD)

Overview

The purpose of this study is to investigate the efficacy of combined intravitreal therapy with or without prior photodynamic therapy in patients with wet age-related macular degeneration (AMD). In patients with wet AMD, a significant improvement in vision was observed after combined intravitreal therapy with or without prior photodynamic therapy. Both the pharmacological effects of the drugs and the physiological effects of the pars plana vitrectomy (posterior vitreous detachment, liquefaction, and oxygen redistribution) may have contributed to the long-term sustainability of the therapeutic benefits.

Full Title of Study: “Combined Therapy in ARMD – Retrospective Case Series”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2008

Detailed Description

This prospective study of a case series included eyes with predominantly classic lesions (Group 1; n = 52) and eyes with occult lesions (Group 2; n = 106). Patients with predominantly classic lesions received low fluorescence photodynamic therapy (42 J/cm2 for 72 sec), followed by, 24 hours later, a 1.5 mL core pars plana vitrectomy with intravitreal injection of dexamethasone (0.8 mg) and bevacizumab (1.25 mg). Patients with occult lesions received a 0.4 mL core pars plana vitrectomy with intravitreal injection of triamcinolone (8 mg) and bevacizumab (1.25 mg). At baseline and follow-up examinations, the best-corrected visual acuity (BCVA; logMar), central macular thickness (optical coherence tomography), intraocular pressure (IOP; Goldmann tonometry) were determined. In addition, the need for retreatment was assessed, and adverse events were monitored.

Interventions

  • Procedure: Low fluorescence Photodynamic therapy
    • 42 J/cm2 for 72 sec
  • Procedure: core pars plana vitrectomy
    • 24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy
  • Drug: dexamethasone
    • intravitreal injection of 0.8 mg dexamethasone
  • Drug: bevacizumab
    • intravitreal injection of 1.25 mg bevacizumab
  • Procedure: core pars plana vitrectomy
    • 0.4 mL core pars plana vitrectomy
  • Drug: triamcincolone
    • intravitreal injection of 8 mg triamcincolone

Arms, Groups and Cohorts

  • Experimental: 1
    • eyes with predominately classic lesions
  • Experimental: 2
    • eyes with occult lesions

Clinical Trial Outcome Measures

Primary Measures

  • Best corrected visual acuity
    • Time Frame: at the day of exam
  • Central macular thickness
    • Time Frame: at the day of exam

Participating in This Clinical Trial

Inclusion Criteria

  • Wet age related macular degeneration Exclusion Criteria:
  • Opacities in lens or cornea – Ongoing intraocular inflammation – Trauma
  • Gender Eligibility: All

    Minimum Age: N/A

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Johann Wolfgang Goethe University Hospital
    • Provider of Information About this Clinical Study
      • Principal Investigator: Michael Koss, PI – Johann Wolfgang Goethe University Hospital

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