Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the association of bevacizumab and PDT is safety and effective in the treatment of exudative AMD
Exudative AMD is the leader of blind in people more than 60 years. The best treatment for this disease today are monthly injections of anti-VEGF in the vitreous cavity which increase the chance to get endophthalmites.
The participants of this study will be randomized in 1:1 ration to one of the two study groups: single therapy of bevacizumab (3 injections in 3 months) or association of bevacizumab (3 injections in 3 months) and full fluence of PDT (single at the baseline). All bevacizumab injection will contain 1.25g of the drug and will be administrate every month for 3 continuos months.
After randomization, participants will return to the clinic approximately every four weeks for 4 months for study assessments and possible re-treatment (if is necessary). Participants will return to the clinic at week 20 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography and fundus photography.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | 1.25 mg of bevacizumab intravitreal |
| |
| vetaporfin |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months | 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The overall probability of re-injection | 4 | |
| Proportion of participants with reduction in retinal thickening in the center subfield (i.e., thickness > 200 microns) of ³50% and of at least 50 microns from baseline | 4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anderson G Teixeira, MD | Contact | 323-442-6672 | anderson.lbo@uol.com.br | |
| Roberta Velletri, MD | Contact | 11-5511-5085-2041 | dravelletri@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNIFESP | Recruiting | São Paulo | São Paulo | 04023-062 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18463509 | Background | Smith BT, Dhalla MS, Shah GK, Blinder KJ, Ryan EH Jr, Mittra RA. Intravitreal injection of bevacizumab combined with verteporfin photodynamic therapy for choroidal neovascularization in age-related macular degeneration. Retina. 2008 May;28(5):675-81. doi: 10.1097/IAE.0b013e31816b316e. | |
| 18462575 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
full fluence of vetaporfin |
|
| Mean change in area of leakage, CNV and lesion by the FA and ICG | 4 |
| Colquitt JL, Jones J, Tan SC, Takeda A, Clegg AJ, Price A. Ranibizumab and pegaptanib for the treatment of age-related macular degeneration: a systematic review and economic evaluation. Health Technol Assess. 2008 May;12(16):iii-iv, ix-201. doi: 10.3310/hta12160. |
| 18320527 | Background | Ahmadieh H, Taei R, Soheilian M, Riazi-Esfahani M, Ahadi H. Single-session photodynamic therapy combined with intravitreal bevacizumab for neovascular age-related macular degeneration. Eur J Ophthalmol. 2008 Mar-Apr;18(2):297-300. doi: 10.1177/112067210801800222. |
| 18303156 | Background | Weigert G, Michels S, Sacu S, Varga A, Prager F, Geitzenauer W, Schmidt-Erfurth U. Intravitreal bevacizumab (Avastin) therapy versus photodynamic therapy plus intravitreal triamcinolone for neovascular age-related macular degeneration: 6-month results of a prospective, randomised, controlled clinical study. Br J Ophthalmol. 2008 Mar;92(3):356-60. doi: 10.1136/bjo.2007.125823. |
| 17923543 | Background | Bashshur ZF, Schakal A, Hamam RN, El Haibi CP, Jaafar RF, Noureddin BN. Intravitreal bevacizumab vs verteporfin photodynamic therapy for neovascular age-related macular degeneration. Arch Ophthalmol. 2007 Oct;125(10):1357-61. doi: 10.1001/archopht.125.10.1357. |
| 17891013 | Background | Ladas ID, Kotsolis AI, Papakostas TD, Rouvas AA, Karagiannis DA, Vergados I. Intravitreal bevacizumab combined with photodynamic therapy for the treatment of occult choroidal neovascularization associated with serous pigment epithelium detachment in age-related macular degeneration. Retina. 2007 Sep;27(7):891-6. doi: 10.1097/IAE.0b013e3180ca9ad9. |
| 17701197 | Background | Ladewig MS, Karl SE, Hamelmann V, Helb HM, Scholl HP, Holz FG, Eter N. Combined intravitreal bevacizumab and photodynamic therapy for neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2008 Jan;246(1):17-25. doi: 10.1007/s00417-007-0654-x. Epub 2007 Aug 15. |
| 17564719 | Background | Hahn R, Sacu S, Michels S, Varga A, Weigert G, Geitzenauer W, Vecsei-Marlovits P, Schmidt-Erfurth U. [Intravitreal bevacizumab versus verteporfin and intravitreal triamcinolone acetonide in patients with neovascular age-related macula degeneration]. Ophthalmologe. 2007 Jul;104(7):588-93. doi: 10.1007/s00347-007-1547-4. German. |
| 17544776 | Background | Lazic R, Gabric N. Verteporfin therapy and intravitreal bevacizumab combined and alone in choroidal neovascularization due to age-related macular degeneration. Ophthalmology. 2007 Jun;114(6):1179-85. doi: 10.1016/j.ophtha.2007.03.006. |
| 17469756 | Background | Lazic R, Gabric N, Dekaris I, Gavric M, Bosnar D. Photodynamic therapy combined with intravitreal bevacizumab (Avastin) in treatment of choroidal neovascularization secondary to age-related macular degeneration. Coll Antropol. 2007 Jan;31 Suppl 1:71-5. |
| 17333238 | Background | Costa RA, Jorge R, Calucci D, Melo LA Jr, Cardillo JA, Scott IU. Intravitreal bevacizumab (Avastin) in combination with verteporfin photodynamic therapy for choroidal neovascularization associated with age-related macular degeneration (IBeVe Study). Graefes Arch Clin Exp Ophthalmol. 2007 Sep;245(9):1273-80. doi: 10.1007/s00417-007-0557-x. Epub 2007 Feb 28. |
| 17290193 | Background | Augustin AJ, Puls S, Offermann I. Triple therapy for choroidal neovascularization due to age-related macular degeneration: verteporfin PDT, bevacizumab, and dexamethasone. Retina. 2007 Feb;27(2):133-40. doi: 10.1097/IAE.0b013e3180323de7. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |