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Completed

NCT Number: NCT00805649

Combined Therapy in Age-Related Macular Degeneration (ARMD)

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Abteilung für Netzhaut und Glaskörperchirurgie

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Wet age related macular degeneration

Exclusion criteria

  • Opacities in lens or cornea
  • Ongoing intraocular inflammation
  • Trauma

Treatment and study plan

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

triamcincolone

Drug

intravitreal injection of 8 mg triamcincolone

Primary outcomes

  1. Best corrected visual acuity

    Time frame: at the day of exam

  2. Central macular thickness

    Time frame: at the day of exam

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Combined Therapy in ARMD - Retrospective Case Series

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 9, 2008
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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