Combined Therapy in Age-Related Macular Degeneration (ARMD)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Michael Koss, Johann Wolfgang Goethe University Hospitals

ClinicalTrials.gov Identifier:

NCT00805649

First received: December 8, 2008

Last updated: September 26, 2012

Last verified: September 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Age-Related Macular Degeneration	Procedure: Low fluorescence Photodynamic therapy Procedure: core pars plana vitrectomy Drug: dexamethasone Drug: bevacizumab Drug: triamcincolone	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Combined Therapy in ARMD - Retrospective Case Series

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Bevacizumab

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

Best corrected visual acuity [ Time Frame: at the day of exam ] [ Designated as safety issue: No ]
Central macular thickness [ Time Frame: at the day of exam ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	January 2006
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
Experimental: 2 eyes with occult lesions	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

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Wet age related macular degeneration

Exclusion Criteria:

Opacities in lens or cornea
Ongoing intraocular inflammation
Trauma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805649

Locations

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

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

More Information

No publications provided

Responsible Party:	Michael Koss, PI, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00805649 History of Changes
Other Study ID Numbers:	MK-KTAMD-2008
Study First Received:	December 8, 2008
Last Updated:	September 26, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:

ARMD
combined therapy
efficacy
safety

Additional relevant MeSH terms:

Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bevacizumab
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013

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