NCT00805649

Combined Therapy in Age-Related Macular Degeneration (ARMD)

Combined Therapy in ARMD - Retrospective Case Series

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-06-01
• Completion: 2008-07-01
• First posted: 2008-12-09
• Last updated: 2012-09-27

Locations

1 site across 1 country: Germany