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Ranibizumab and Reduced Fluence PDT for AMD (RAP)

Primary Purpose

Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ranibizumab

verteporfin

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Anti-VEGF therapy, photodynamic therapy, neovascularization

Eligibility Criteria

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

Inclusion Criteria:

Willingness to sign informed consent.
Age greater than 50.
Evidence of macular degeneration in the form of drusen in either eye.
Visual acuity of 20/25 to 20/800.
Subfoveal choroidal neovascularization. Both occult and classic subtypes will be allowed. If lesion is purely occult there has to be one of the following:
1. Recent loss of vision (5 letters on ETDRS or doubling of visual angle by snellen)
2. Documented enlargement of lesion on FA
3. Increase of 50 microns or more in the central subfield on OCT
4. New blood
Total active lesion must be less than 12 disc areas in size. -

Exclusion Criteria:

Myopia, ocular histoplasmosis, or other retinal pathology that could affect vision
Previous treatment of the enrolled eye for CNV
Intraocular surgery within 6 weeks of enrollment
Geographic atrophy, subretinal fibrosis, or pigment epithelial tear involving the fovea of the eligible eye
Known hypersensitivity to verteporfin
Medical condition that would preclude regular follow-up for one year.
Previous vitrectomy
Media opacities limiting visual acuity, retinal examination, or retinal imaging.
A lesion where > 50% of the lesion is a pigment epithelial detachment. -

Sites / Locations

California Retina Consultants & Research Foundation
Associated Retinal Consultants
Texas Retina Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I

Group II

Arm Description

Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.

Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.

Outcomes

Primary Outcome Measures

The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.

Secondary Outcome Measures

The Number of Days to Retreatment. The Total Number of Treatments Given Over One Year. The Percentage of Patients With More Than a 15 Letter Increase in Vision at 12 Months. The Mean Change in Macular Volume as Measured by OCT at 3, 6, and 12 Months.

Full Information

NCT ID

NCT00527475

First Posted

September 9, 2007

Last Updated

June 5, 2013

Sponsor

Texas Retina Associates

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00527475

Brief Title

Ranibizumab and Reduced Fluence PDT for AMD

Acronym

RAP

Official Title

Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Texas Retina Associates

Collaborators

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set the standard for visual outcomes in treating wet macular degeneration. However, they need to be administered frequently by intraocular injections with the attendant risk of endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of this trial is to see if using photodynamic therapy in combination with ranibizumab will decrease the number of treatments with ranibizumab.

Detailed Description

A randomized, prospective, multicenter trial will compare two groups of patients with subfoveal choroidal neovascularization secondary to AMD. One group will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. The other group will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year. Re-treatment will be determined by the individual investigator based on visual acuity, retinal thickness as measured by optical coherence tomography (OCT), and fluorescein angiography. Visual acuity and OCT measurements will be performed by masked examiners.

6. Conditions and Keywords

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

Macular Degeneration

Keywords

Anti-VEGF therapy, photodynamic therapy, neovascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Active Comparator

Arm Description

Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.

Arm Title

Group II

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ranibizumab

Intervention Description

0.5 mg. given as an intraocular injection

Intervention Type

Drug

Intervention Name(s)

verteporfin

Intervention Description

Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.

Primary Outcome Measure Information:

Title

The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Willingness to sign informed consent. Age greater than 50. Evidence of macular degeneration in the form of drusen in either eye. Visual acuity of 20/25 to 20/800. Subfoveal choroidal neovascularization. Both occult and classic subtypes will be allowed. If lesion is purely occult there has to be one of the following: Recent loss of vision (5 letters on ETDRS or doubling of visual angle by snellen) Documented enlargement of lesion on FA Increase of 50 microns or more in the central subfield on OCT New blood Total active lesion must be less than 12 disc areas in size. - Exclusion Criteria: Myopia, ocular histoplasmosis, or other retinal pathology that could affect vision Previous treatment of the enrolled eye for CNV Intraocular surgery within 6 weeks of enrollment Geographic atrophy, subretinal fibrosis, or pigment epithelial tear involving the fovea of the eligible eye Known hypersensitivity to verteporfin Medical condition that would preclude regular follow-up for one year. Previous vitrectomy Media opacities limiting visual acuity, retinal examination, or retinal imaging. A lesion where > 50% of the lesion is a pigment epithelial detachment. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Callanan, MD

Organizational Affiliation

Texas Retina Associates

Official's Role

Study Chair

Facility Information:

Facility Name

California Retina Consultants & Research Foundation

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93103

Country

United States

Facility Name

Associated Retinal Consultants

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

49301

Country

United States

Facility Name

Texas Retina Associates

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

12. IPD Sharing Statement

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Ranibizumab and Reduced Fluence PDT for AMD

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