Combined Therapy in Age-Related Macular Degeneration (ARMD)

Age-Related Macular Degeneration Clinical Trial

Official title:

Combined Therapy in ARMD - Retrospective Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805649
• Other study ID #: MK-KTAMD-2008
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2008
• Last updated: September 26, 2012
• Start date: January 2006
• Est. completion date: July 2008

Study information

• Verified date: September 2012
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Wet age related macular degeneration

Exclusion Criteria:

• Opacities in lens or cornea

• Ongoing intraocular inflammation

• Trauma

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Procedure:
• Low fluorescence Photodynamic therapy
42 J/cm2 for 72 sec
• 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
• 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

Locations

Country	Name	City	State
Germany	Abteilung für Netzhaut und Glaskörperchirurgie	Frankfurt/Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity		at the day of exam	No
Primary	Central macular thickness		at the day of exam	No