Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration
Recruitment status was Recruiting
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Purpose
The purpose of this study is to determine if of combination therapy of intravitreal bevacizumab 4 days after the application of photodynamic therapy could improve the visual outcomes of patients with neovascular age related macular degeneration.
| Condition | Intervention | Phase |
|---|---|---|
|
Age Related Macular Degeneration |
Drug: bevacizumab intravitreal injection Procedure: verteporfin photodynamic therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Intravitreal Injection of Bevacizumab in Combination With Verteporfin Photodynamic Therapy |
- Visual acuity improvement at 6 months
- Retinal thickness improvement at 6 months
| Estimated Enrollment: | 25 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | June 2007 |
The neovascular age related macular degeneration(AMD) is a important cause of legal blindness in adults older than 50 years. Currently the treatment is photodynamic therapy that offer stabilization and limited visual improvement after 2 years of therapy. Bevacizumab has been reported effective used as intravenous injection for AMD. But serious side effects have been reported with the use of this drug in oncologic patients. The intravitreal use has been reported in limited case reports and safety and efficacy should be determined. The purpose of this study is efficacy and safety of 2.5 mg intravitreal of bevacizumab for AMD 4 days after photodynamic therapy with verteporfin
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
55 years old neovascular Age related acular degeneration subfoveolar neovascular membrane best corrected visual acuity better than 20/200 snellen (1.0 logMAR)
Exclusion Criteria:
- Previously treated eyes glaucoma diabetes mellitus uncontrolled hypertension coronary artery disease
Contacts and Locations| Contact: Dalma Jose Dalma-Weizhaus | 10841400 ext 1171 | draojitos26@hotmail.com |
| Mexico | |
| Hospital Luis Sanchez Bulnes | Recruiting |
| Mexico city, DF, Mexico, 04030 | |
| Contact: Hugo Quiroz-Mercado, MD 525510841400 retinamex@yahoo.com | |
| Principal Investigator: Maura L Abraham Marin, MD | |
| Study Director: | Hugo Quiroz-Mercado, MD | Asociacion para evitar la ceguera en Mexico |
| Principal Investigator: | Jose Dalma Weizhaus, MD | Asociacion para evitar la ceguera en Mexico |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00347399 History of Changes |
| Other Study ID Numbers: | AvastinTFD |
| Study First Received: | June 30, 2006 |
| Last Updated: | June 30, 2006 |
| Health Authority: | Mexico: Ministry of Health |
Keywords provided by Asociación para Evitar la Ceguera en México:
|
macular degeneration antibodies angiogenesis inhibitor |
Additional relevant MeSH terms:
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Angiogenesis Inhibitors Bevacizumab Verteporfin Angiogenesis Modulating Agents |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses Photosensitizing Agents Radiation-Sensitizing Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013