Comparative Study With Photodynamic Therapy And Triamcinolone Versus Photodynamic Therapy, Triamcinolone And Ranibizumab In Patients With Subfoveal Choroidal Neovascularization
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Subfoveal Choroidal Neovascularization |
Drug: intravitreal injection of ranibizumab Drug: intravitreal injection of triamcinolone Procedure: photodynamic therapy |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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) |
- 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
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | September 2006 |
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.
:
Eligibility| Ages Eligible for Study: | 20 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
- Any visual acuity
Exclusion Criteria:
- Previous treatment
- Glaucoma
Contacts and Locations| Contact: Rosa M Romero, MD | 7221600451 | rromerocastro@yahoo.com |
| Contact: Hugo Quiroz-Mercado, MD | 525510841400 ext 1171 | retinamex@yahoo.com |
| Mexico | |
| Centro Medico Isemmym | Recruiting |
| Metepec, Estado-de-Mexico, Mexico, 52140 | |
| Contact: Rosa M Romero, MD 7221600451 rromerocastro@yahoo.com | |
| Contact: Hugo Quiroz-Mercado, MD 52555108414000 ext 1171 retinamex@yahoo.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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00930189 History of Changes |
| Other Study ID Numbers: | APEC-0031 |
| Study First Received: | December 1, 2006 |
| Last Updated: | June 29, 2009 |
| Health Authority: | Mexico: Secretaria de Salud |
Keywords provided by Asociación para Evitar la Ceguera en México:
|
age related macular degeneration |
Additional relevant MeSH terms:
|
Macular Degeneration Neovascularization, Pathologic Choroidal Neovascularization Retinal Degeneration Retinal Diseases Eye Diseases Metaplasia Pathologic Processes Choroid Diseases Uveal Diseases Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide |
Triamcinolone diacetate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013