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| Sponsored by: |
Johann Wolfgang Goethe University Hospitals |
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| Information provided by: | Johann Wolfgang Goethe University Hospitals |
| ClinicalTrials.gov Identifier: | NCT00805649 |
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 |
|---|---|
|
Age-Related Macular Degeneration |
Procedure: Low fluorescence Photodynamic therapy Procedure: core pars plana vitrectomy Drug: dexamethasone Drug: bevacizumab Drug: triamcincolone |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Combined Therapy in ARMD - Retrospective Case Series |
| 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 |
|---|---|
|
1: Experimental
eyes with predominately classic lesions
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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
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2: Experimental
eyes with occult lesions
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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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Zentrum für Augenheilkunde ( Prof Dr Koch ) |
| Study ID Numbers: | MK-KTAMD-2008 |
| Study First Received: | December 8, 2008 |
| Last Updated: | March 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00805649 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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ARMD combined therapy efficacy safety |
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Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents, Hormonal Hormone Antagonists Eye Diseases Temazepam Hormones, Hormone Substitutes, and Hormone Antagonists Macular Degeneration Retinal Degeneration |
Antiemetics Bevacizumab Angiogenesis Inhibitors Glucocorticoids Hormones Peripheral Nervous System Agents Retinal Diseases Dexamethasone acetate |
|
Dexamethasone Anti-Inflammatory Agents Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Bevacizumab Hormones Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Dexamethasone acetate Retinal Diseases |
Antineoplastic Agents, Hormonal Eye Diseases Growth Substances Gastrointestinal Agents Retinal Degeneration Macular Degeneration Glucocorticoids Angiogenesis Inhibitors Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
