Combined Therapy in Age-Related Macular Degeneration (ARMD)

Combined Therapy in ARMD - Retrospective Case Series

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.

Study Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Procedure: Low fluorescence Photodynamic therapy; Procedure: core pars plana vitrectomy; Drug: dexamethasone; Drug: bevacizumab; Procedure: core pars plana vitrectomy; Drug: triamcincolone

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt/Main, Hessen, Germany, 60590
      • Abteilung für Netzhaut und Glaskörperchirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Wet age related macular degeneration

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; eyes with predominately classic lesions	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
Experimental: 2; eyes with occult lesions	Procedure: core pars plana vitrectomy; 24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Best corrected visual acuity	at the day of exam
Central macular thickness	at the day of exam

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: December 8, 2008
• First Submitted That Met QC Criteria: December 8, 2008
• First Posted (Estimate): December 9, 2008

Study Record Updates

• Last Update Posted (Estimate): September 27, 2012
• Last Update Submitted That Met QC Criteria: September 26, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: safety; efficacy; ARMD; combined therapy
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Dexamethasone; Bevacizumab; Temazepam
• Other Study ID Numbers: MK-KTAMD-2008