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Comparative Study With Photodynamic Therapy And Triamcinolone Versus Photodynamic Therapy, Triamcinolone And Ranibizumab In Patients With Subfoveal Choroidal Neovascularization

Primary Purpose

Subfoveal Choroidal Neovascularization

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
intravitreal injection of ranibizumab
intravitreal injection of triamcinolone
photodynamic therapy
Sponsored by
Asociación para Evitar la Ceguera en México
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subfoveal Choroidal Neovascularization focused on measuring age related macular degeneration

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
  • Any visual acuity

Exclusion Criteria:

  • Previous treatment
  • Glaucoma

Sites / Locations

  • Centro Medico IsemmymRecruiting

Outcomes

Primary Outcome Measures

The main outcome measures were visual acuity (VA)
mean change in lesion size
mean change in foveal thickness

Secondary Outcome Measures

retreatment rate
the incidence and severity of adverse events

Full Information

First Posted
December 1, 2006
Last Updated
June 29, 2009
Sponsor
Asociación para Evitar la Ceguera en México
Collaborators
Centro Medico Issemym
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1. Study Identification

Unique Protocol Identification Number
NCT00930189
Brief Title
Comparative Study With Photodynamic Therapy And Triamcinolone Versus Photodynamic Therapy, Triamcinolone And Ranibizumab In Patients With Subfoveal Choroidal Neovascularization
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 Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Asociación para Evitar la Ceguera en México
Collaborators
Centro Medico Issemym

4. Oversight

5. Study Description

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.
Detailed Description
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. :

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfoveal Choroidal Neovascularization
Keywords
age related macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
intravitreal injection of ranibizumab
Intervention Type
Drug
Intervention Name(s)
intravitreal injection of triamcinolone
Intervention Type
Procedure
Intervention Name(s)
photodynamic therapy
Primary Outcome Measure Information:
Title
The main outcome measures were visual acuity (VA)
Title
mean change in lesion size
Title
mean change in foveal thickness
Secondary Outcome Measure Information:
Title
retreatment rate
Title
the incidence and severity of adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) Any visual acuity Exclusion Criteria: Previous treatment Glaucoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosa M Romero, MD
Phone
7221600451
Email
rromerocastro@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hugo Quiroz-Mercado, MD
Phone
525510841400
Ext
1171
Email
retinamex@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa M Romero, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Medico Isemmym
City
Metepec
State/Province
Estado-de-Mexico
ZIP/Postal Code
52140
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa M Romero, MD
Phone
7221600451
Email
rromerocastro@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hugo Quiroz-Mercado, MD
Phone
52555108414000
Ext
1171
Email
retinamex@yahoo.com
First Name & Middle Initial & Last Name & Degree
Gerardo Monares, MD
First Name & Middle Initial & Last Name & Degree
Alfredo Morales, MD
First Name & Middle Initial & Last Name & Degree
Juan-Carlos De-la Luz, MD
First Name & Middle Initial & Last Name & Degree
Antonio Niño, MD
First Name & Middle Initial & Last Name & Degree
Gonzalo Padilla, MD
First Name & Middle Initial & Last Name & Degree
Hugo Quiroz-Mercado, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16996600
Citation
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.
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Comparative Study With Photodynamic Therapy And Triamcinolone Versus Photodynamic Therapy, Triamcinolone And Ranibizumab In Patients With Subfoveal Choroidal Neovascularization

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