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Combined Therapy in Age-Related Macular Degeneration (ARMD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00805649
First Posted: December 9, 2008
Last Update Posted: September 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Koss, Johann Wolfgang Goethe University Hospitals
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Therapy in ARMD - Retrospective Case Series

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: at the day of exam ]
  • Central macular thickness [ Time Frame: at the day of exam ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805649


Locations
Germany
Abteilung für Netzhaut und Glaskörperchirurgie
Frankfurt/Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
  More Information

Responsible Party: Michael Koss, PI, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00805649     History of Changes
Other Study ID Numbers: MK-KTAMD-2008
First Submitted: December 8, 2008
First Posted: December 9, 2008
Last Update Posted: September 27, 2012
Last Verified: September 2012

Keywords provided by Michael Koss, 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
Bevacizumab
BB 1101
Temazepam
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents