Ranibizumab and Reduced Fluence PDT for AMD

Macular Degeneration Clinical Trial

— RAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527475
• Other study ID #: RAP AMD Trial
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2007
• Last updated: June 5, 2013
• Start date: May 2007
• Est. completion date: January 2010

Study information

• Verified date: June 2013
• Source: Texas Retina Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Willingness to sign informed consent.

2. Age greater than 50.

3. Evidence of macular degeneration in the form of drusen in either eye.

4. Visual acuity of 20/25 to 20/800.

5. 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

6. Total active lesion must be less than 12 disc areas in size. -

Exclusion Criteria:

1. Myopia, ocular histoplasmosis, or other retinal pathology that could affect vision

2. Previous treatment of the enrolled eye for CNV

3. Intraocular surgery within 6 weeks of enrollment

4. Geographic atrophy, subretinal fibrosis, or pigment epithelial tear involving the fovea of the eligible eye

5. Known hypersensitivity to verteporfin

6. Medical condition that would preclude regular follow-up for one year.

7. Previous vitrectomy

8. Media opacities limiting visual acuity, retinal examination, or retinal imaging.

9. A lesion where > 50% of the lesion is a pigment epithelial detachment. -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration

Intervention

Drug:
• ranibizumab
0.5 mg. given as an intraocular injection
• verteporfin
Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.

Locations

Country	Name	City	State
United States	Associated Retinal Consultants	Ann Arbor	Michigan
United States	Texas Retina Associates	Arlington	Texas
United States	California Retina Consultants & Research Foundation	Santa Barbara	California

Sponsors (2)

Lead Sponsor	Collaborator
Texas Retina Associates	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.		1 year	Yes
Secondary	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.		1 year	No