Combined Therapy in Age-Related Macular Degeneration (ARMD)

NCT ID: NCT00805649

Last Updated: 2012-09-27

Basic Information

• 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

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.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

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

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael Koss

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Abteilung für Netzhaut und Glaskörperchirurgie

Frankfurt am Main, Hesse, Germany

Countries

Germany

Other Identifiers

MK-KTAMD-2008

Identifier Type: -

Identifier Source: org_study_id