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Comparative Study With Photodynamic Therapy And Triamcinolone Versus Photodynamic Therapy, Triamcinolone And Ranibizumab In Patients With Subfoveal Choroidal Neovascularization
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)
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2006
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 1, 2006
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedMay 30, 2024
May 1, 2024
Same day
December 1, 2006
May 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The main outcome measures were visual acuity (VA)
mean change in lesion size
mean change in foveal thickness
Secondary Outcomes (2)
retreatment rate
the incidence and severity of adverse events
Interventions
Eligibility Criteria
You may qualify if:
- Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
- Any visual acuity
You may not qualify if:
- Previous treatment
- Glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asociación para Evitar la Ceguera en Méxicolead
- Centro Medico Issemymcollaborator
Study Sites (1)
Centro Medico Isemmym
Metepec, State of Mexico, 52140, Mexico
Related Publications (1)
Arias L, Garcia-Arumi J, Ramon JM, Badia M, Rubio M, Pujol O. Photodynamic therapy with intravitreal triamcinolone in predominantly classic choroidal neovascularization: one-year results of a randomized study. Ophthalmology. 2006 Dec;113(12):2243-50. doi: 10.1016/j.ophtha.2006.04.039. Epub 2006 Sep 25.
PMID: 16996600BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rosa M Romero, MD
Asociación para Evitar la Ceguera en México
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 1, 2006
First Posted
June 30, 2009
Study Start
April 1, 2006
Primary Completion
April 1, 2006
Study Completion
September 1, 2006
Last Updated
May 30, 2024
Record last verified: 2024-05