Combined Therapy in Age-Related Macular Degeneration (ARMD)

Phase 4

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: bevacizumab; Procedure: Low fluorescence Photodynamic therapy; Procedure: core pars plana vitrectomy; Drug: dexamethasone; Drug: triamcincolone

• Registration Number: NCT00805649
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-06
• Study Completion: 2008-07
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-26
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Wet age related macular degeneration

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	bevacizumab	eyes with occult lesions
1	Low fluorescence Photodynamic therapy	eyes with predominately classic lesions
1	bevacizumab	eyes with predominately classic lesions
1	core pars plana vitrectomy	eyes with predominately classic lesions
1	dexamethasone	eyes with predominately classic lesions
2	core pars plana vitrectomy	eyes with occult lesions
2	triamcincolone	eyes with occult lesions

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity	at the day of exam
Central macular thickness	at the day of exam

Trial Locations

Locations (1)

Abteilung für Netzhaut und Glaskörperchirurgie; 🇩🇪 Frankfurt/Main, Hessen, Germany