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| Sponsored by: |
Asociación para Evitar la Ceguera en México |
|---|---|
| Information provided by: | Asociación para Evitar la Ceguera en México |
| ClinicalTrials.gov Identifier: | NCT00347399 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Effects of Intravitreal Injection of Bevacizumab in Combination With Verteporfin Photodynamic Therapy |
| 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:
Contacts and Locations| Contact: Dalma Jose Dalma-Weizhaus | 10841400 ext 1171 | draojitos26@hotmail.com |
| Mexico, DF | |
| 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
| Study ID Numbers: | AvastinTFD |
| Study First Received: | June 30, 2006 |
| Last Updated: | June 30, 2006 |
| ClinicalTrials.gov Identifier: | NCT00347399 |
| Health Authority: | Mexico: Ministry of Health |
|
macular degeneration antibodies angiogenesis inhibitor |
|
Antibodies Eye Diseases Verteporfin Retinal Degeneration Macular Degeneration |
Bevacizumab Retinal Diseases Immunoglobulins Retinal degeneration |
|
Photosensitizing Agents Radiation-Sensitizing Agents Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Dermatologic Agents Pharmacologic Actions |
