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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centro Medico Issemym
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00930189
First received: December 1, 2006
Last updated: June 29, 2009
Last verified: December 2006
  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)

Resource links provided by NLM:


Further study details as provided by Asociación para Evitar la Ceguera en México:

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

Estimated Enrollment: 100
Study Start Date: April 2006
Estimated Study Completion Date: September 2006
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.

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  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous treatment
  • Glaucoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930189

Contacts
Contact: Rosa M Romero, MD 7221600451 rromerocastro@yahoo.com
Contact: Hugo Quiroz-Mercado, MD 525510841400 ext 1171 retinamex@yahoo.com

Locations
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         
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Centro Medico Issemym
Investigators
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 July 22, 2014