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

Sponsor

Asociación para Evitar la Ceguera en México (Other)

Overall Status

Unknown status

CT.gov ID

NCT00930189

Collaborator

Centro Medico Issemym (Other)

100

Enrollment

Location

Duration (Months)

19.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Subfoveal Choroidal Neovascularization	Drug: intravitreal injection of ranibizumab Drug: intravitreal injection of triamcinolone Procedure: photodynamic therapy	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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)

Study Start Date :

Apr 1, 2006

Anticipated Study Completion Date :

Sep 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

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

Locations

	Site	City	State	Country	Postal Code
1	Centro Medico Isemmym	Metepec	Estado-de-Mexico	Mexico	52140

Sponsors and Collaborators

Asociación para Evitar la Ceguera en México
Centro Medico Issemym

Investigators

Principal Investigator: Rosa M Romero, MD, Asociación para Evitar la Ceguera en México

Study Documents (Full-Text)

None provided.

More Information

Publications

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. Epub 2006 Sep 25.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00930189

Other Study ID Numbers:

APEC-0031

First Posted:

Jun 30, 2009

Last Update Posted:

Jun 30, 2009

Last Verified:

Dec 1, 2006

Keywords provided by , ,

age related macular degeneration

Additional relevant MeSH terms:

Choroidal Neovascularization

Neovascularization, Pathologic

Triamcinolone

Ranibizumab

Study Results

No Results Posted as of Jun 30, 2009