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Combined Therapy in Age-Related Macular Degeneration (ARMD)

NCT00805649 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-09-27

No results posted yet for this study

Summary

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.

Conditions

  • Age-Related Macular Degeneration

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

Sponsors & Collaborators

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-06-30
Completion
2008-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00805649 on ClinicalTrials.gov