Comparative Study With Photodynamic Therapy And Triamcinolone Versus Photodynamic Therapy, Triamcinolone And Ranibizumab In Patients With Subfoveal Choroidal Neovascularization
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|ClinicalTrials.gov Identifier: NCT00930189|
Recruitment Status : Unknown
Verified December 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was: Recruiting
First Posted : June 30, 2009
Last Update Posted : June 30, 2009
The purpose of this study is to compare the efficacy of photodynamic therapy with verteporfin (PDT) and IVTA vs triple therapy (TT) in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
The investigators designed a prospective, comparative, randomized, double blind, controlled study. 15 patients with classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized. Triple therapy can potentially offer a new treatment modality for choroidal neovascularization in patients with macular degeneration and other diseases.
|Condition or disease||Intervention/treatment||Phase|
|Subfoveal Choroidal Neovascularization||Drug: intravitreal injection of ranibizumab Drug: intravitreal injection of triamcinolone Procedure: photodynamic therapy||Phase 2 Phase 3|
Purpose: To compare the efficacy of photodynamic therapy with verteporfin (PDT) and IVTA vs triple therapy (TT) in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Methods: Prospective, comparative, randomized, double blind, controlled study. 15 patients with classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized. Group 1: receive PDT followed by 4 mg IVTA (n=7) or group 2: TT (triple Therapy) PDT followed by 4 mg IVTA + 0.5 mg Ranibizumab (n=8).The main outcome measures were visual acuity (VA), mean change in lesion size, mean change in foveal thickness, retreatment rate and the incidence and severity of adverse events.
Results: At 6 months 5 of 7 patients (71.4%) of group 1 and 8 of 8 patients (100% ) of group 2 had lost fewer than 15 letters (P<.001). Three patients (37.5%) of group 2 had an improvement of 3 lines or more. Lesion type, patient age, and lesion size had no influence on the outcome, but baseline VA had a statistically significant effect (P =.006). The median number of treatments in both groups was one. The 28% of PDT-triamcinolone group and 25% of triple therapy group had an increase in intraocular pressure (IOP) that required therapy. Progression or development of cataract was observed in 14.2 % in PDT- IVTA group and 12.5% in Triple therapy group. There were no cases of endophthalmitis. No cardiac or cerebrovascular accidents where presented.
Conclusions: The combination of PDT, intravitreal triamcinolone acetonide and intravitreal ranibizumab is a safe treatment option for neovascular AMD and prevents a considerable decrease in VA. In our patients it seems to be superior than combinated therapy with PDT and triamcinolone.
Clinical Relevance: Triple therapy can potentially offer a new treatment modality for choroidal neovascularization in patients with macular degeneration and other diseases.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized, Double Blind, Controlled Study With Verteporfin Photodynamic Therapy And Intravitreal Triamcinolone(IVTA) Vs Triple Therapy With Verteporfin Photodynamic Therapy, Intravitreal Triamcinolone And Intravitreal Ranibizumab In Patients With Subfoveal Choroidal Neovascularization(CNV) Secondary To Age-Related Macular Degeneration(AMD)|
|Study Start Date :||April 2006|
|Estimated Study Completion Date :||September 2006|
- The main outcome measures were visual acuity (VA)
- mean change in lesion size
- mean change in foveal thickness
- retreatment rate
- the incidence and severity of adverse events
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): NCT00930189
|Contact: Rosa M Romero, MDfirstname.lastname@example.org|
|Contact: Hugo Quiroz-Mercado, MD||525510841400 ext email@example.com|
|Centro Medico Isemmym||Recruiting|
|Metepec, Estado-de-Mexico, Mexico, 52140|
|Contact: Rosa M Romero, MD 7221600451 firstname.lastname@example.org|
|Contact: Hugo Quiroz-Mercado, MD 52555108414000 ext 1171 email@example.com|
|Sub-Investigator: Gerardo Monares, MD|
|Sub-Investigator: Alfredo Morales, MD|
|Sub-Investigator: Juan-Carlos De-la Luz, MD|
|Sub-Investigator: Antonio Niño, MD|
|Sub-Investigator: Gonzalo Padilla, MD|
|Sub-Investigator: Hugo Quiroz-Mercado, MD|
|Principal Investigator:||Rosa M Romero, MD||APEC|