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Combined Therapy in Age-Related Macular Degeneration (ARMD)

NCT ID: NCT00805649

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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Age-Related Macular Degeneration

Keywords

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ARMD combined therapy efficacy safety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

eyes with predominately classic lesions

Group Type EXPERIMENTAL

Low fluorescence Photodynamic therapy

Intervention Type PROCEDURE

42 J/cm2 for 72 sec

core pars plana vitrectomy

Intervention Type PROCEDURE

24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy

dexamethasone

Intervention Type DRUG

intravitreal injection of 0.8 mg dexamethasone

bevacizumab

Intervention Type DRUG

intravitreal injection of 1.25 mg bevacizumab

2

eyes with occult lesions

Group Type EXPERIMENTAL

bevacizumab

Intervention Type DRUG

intravitreal injection of 1.25 mg bevacizumab

core pars plana vitrectomy

Intervention Type PROCEDURE

0.4 mL core pars plana vitrectomy

triamcincolone

Intervention Type DRUG

intravitreal injection of 8 mg triamcincolone

Interventions

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Low fluorescence Photodynamic therapy

42 J/cm2 for 72 sec

Intervention Type PROCEDURE

core pars plana vitrectomy

24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy

Intervention Type PROCEDURE

dexamethasone

intravitreal injection of 0.8 mg dexamethasone

Intervention Type DRUG

bevacizumab

intravitreal injection of 1.25 mg bevacizumab

Intervention Type DRUG

core pars plana vitrectomy

0.4 mL core pars plana vitrectomy

Intervention Type PROCEDURE

triamcincolone

intravitreal injection of 8 mg triamcincolone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Wet age related macular degeneration

Exclusion Criteria

* Opacities in lens or cornea
* Ongoing intraocular inflammation
* Trauma
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael Koss

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Abteilung für Netzhaut und Glaskörperchirurgie

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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MK-KTAMD-2008

Identifier Type: -

Identifier Source: org_study_id