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Comparison of Reduced Fluence Versus Standard Photodynamic Therapy (in Combination With Intravitreal Triamcinolone Acetate)

Primary Purpose

Macular Degeneration

Status

Completed

Phase

Phase 3

Locations

Austria

Study Type

Interventional

Intervention

Photodynamic therapy and intravitreal triamcinolone

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring choroidal neovascularisation,, vision,, macula,, macular degeneration, optical coherence tomography, neovascular age related macular degeneration

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Patients 50 years of age or greater.
Patients with subfoveal choroidal neovascularization lesions secondary to AMD.
CNV lesion in the study eye is ≤ 4 disc areas in greatest linear dimension.
Patients who have a BCVA score better than 20/400 in the study eye using ETDRS.
Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study.

Exclusion Criteria:

Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy.
Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye.
Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Visit 1.
History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Visit 1, or a history of post-operative complications within the last 12 months preceding Visit 1 in the study eye (uveitis, cyclitis etc.).
History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation).
Aphakia or absence of the posterior capsule in the study eye.
Presence of a retinal pigment epithelial tear involving the macula in the study eye.
Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the three-month study period to prevent or treat visual loss that might result from that condition.
Active intraocular inflammation (grade trace or above) in the study eye.
Any active infection involving eyeball adnexa.
Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
Ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for three or more consecutive days at any time within six months prior to screening or during the course of the study.

Sites / Locations

Medical University of Vienna, Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

standard fluence photodynamic therapy and intravitreal triamcinolone combination

reduced fluence photodynamic therapy and intravitreal triamcinolone combination

Outcomes

Primary Outcome Measures

• Chorioretinal perfusion. • Perfusion of the neovascular net (CNV). • Changes of intraretinal morphologies. • Central visual function.

Secondary Outcome Measures

macular sensitivity, three dimensional optical coherence tomography

Full Information

NCT ID

NCT00523406

First Posted

August 29, 2007

Last Updated

May 2, 2013

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00523406

Brief Title

Comparison of Reduced Fluence Versus Standard Photodynamic Therapy (in Combination With Intravitreal Triamcinolone Acetate)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To assess the CNV treatment effect of PDT with verteporfin in combination with IVTA using reduced fluence compared to the standard fluence.

Detailed Description

Age-related macular degeneration (AMD) is by far the most common disorder in the group of irreversible causes of visual disability. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD affects visual function early in the disease process and severely compromises the highly developed functions of the macula, such as perception of details, central fixation, color vision, and reading ability. AMD-related visual impairment is associated with a loss of autonomy and quality of life. Currently, laser photocoagulation, photodynamic therapy (PDT) with verteporfin usually combined with intravitreal triamcinolone acetonide (IVTA) are the only proved treatments for subfoveal choroidal neovascularisation (CNV). Laser photocoagulation is limited to selected cases. Photodynamic therapy using verteporfin provides very promising data regarding improvement of visual acuity and absence of fluorescein leakage. PDT was recently successfully combined with an intravitreal injection of the corticosteroid triamcinolone acetonide. Yet, PDT also leads to damage to surrounding normal choroidal vessels. A pilot trial comparing low fluence (300 mW/cm²) with standard fluence (600 mW/cm²) demonstrated a trend for improved outcomes using the low fluence regimen (VIM study). However, vascular mechanisms and choroidal damage were not examined, and the study group was too small to evaluate vision outcome parameters. Combined with the IVTA, the low fluence effects of PDT may be sufficient for CNV occlusion and the physiological choroids should be spared from any collateral damage. The aim of this study was to compare reduced fluence with standard fluence PDT using verteporfin and IVTA for CNV secondary to AMD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Degeneration

Keywords

choroidal neovascularisation,, vision,, macula,, macular degeneration, optical coherence tomography, neovascular age related macular degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

standard fluence photodynamic therapy and intravitreal triamcinolone combination

Arm Title

Arm Type

Active Comparator

Arm Description

reduced fluence photodynamic therapy and intravitreal triamcinolone combination

Intervention Type

Procedure

Intervention Name(s)

Photodynamic therapy and intravitreal triamcinolone

Intervention Description

combination of photodynamic therapy and intravitreal triamcinolone combination to treat neovascular AMD

Primary Outcome Measure Information:

Title

• Chorioretinal perfusion. • Perfusion of the neovascular net (CNV). • Changes of intraretinal morphologies. • Central visual function.

Time Frame

one year

Secondary Outcome Measure Information:

Title

macular sensitivity, three dimensional optical coherence tomography

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patients 50 years of age or greater. Patients with subfoveal choroidal neovascularization lesions secondary to AMD. CNV lesion in the study eye is ≤ 4 disc areas in greatest linear dimension. Patients who have a BCVA score better than 20/400 in the study eye using ETDRS. Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study. Exclusion Criteria: Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy. Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Visit 1. History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Visit 1, or a history of post-operative complications within the last 12 months preceding Visit 1 in the study eye (uveitis, cyclitis etc.). History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation). Aphakia or absence of the posterior capsule in the study eye. Presence of a retinal pigment epithelial tear involving the macula in the study eye. Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the three-month study period to prevent or treat visual loss that might result from that condition. Active intraocular inflammation (grade trace or above) in the study eye. Any active infection involving eyeball adnexa. Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye. Ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for three or more consecutive days at any time within six months prior to screening or during the course of the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ursula Schmidt-Erfurth, MD, Prof.

Organizational Affiliation

Department of Ophthalmology, MUVienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna, Department of Ophthalmology

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

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Comparison of Reduced Fluence Versus Standard Photodynamic Therapy (in Combination With Intravitreal Triamcinolone Acetate)

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