Combined Therapy in Age-Related Macular Degeneration (ARMD)

Sponsor
Johann Wolfgang Goethe University Hospital
Study ID
NCT00805649
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Dec 9, 2008
Start date
Jan 31, 2006
Status verified
Sep 2012
Primary completion
Jun 30, 2008
Completion
Jul 31, 2008

Study Design

Enrollment
150 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Best corrected visual acuity [ Time Frame: at the day of exam ]

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