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

Subfoveal Choroidal Neovascularization Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00930189
• Other study ID #: APEC-0031
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: April 2006
• Est. completion date: September 2006

Study information

• Verified date: May 2024
• Source: Asociación para Evitar la Ceguera en México
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

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

• Any visual acuity

Exclusion Criteria:

• Previous treatment

• Glaucoma

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Neovascularization, Pathologic
• Subfoveal Choroidal Neovascularization

Intervention

Drug:
• intravitreal injection of ranibizumab

• intravitreal injection of triamcinolone

Procedure:
• photodynamic therapy

Locations

Country	Name	City	State
Mexico	Centro Medico Isemmym	Metepec	Estado-de-Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México	Centro Medico Issemym

Country where clinical trial is conducted

Mexico, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main outcome measures were visual acuity (VA)
Primary	mean change in lesion size
Primary	mean change in foveal thickness
Secondary	retreatment rate
Secondary	the incidence and severity of adverse events