Ranibizumab and Reduced Fluence PDT for AMD

Phase 2

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: ranibizumab; Drug: verteporfin

• Registration Number: NCT00527475
• Lead Sponsor: Texas Retina Associates

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-09-09
• Study First Submitted QC: 2007-09-09
• Study First Posted: 2007-09-11
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2013-04-19
• Status Verified: 2013-06
• Results First Submitted QC: 2013-06-05
• Last Update Submitted: 2013-06-05
• Results First Posted: 2013-06-07
• Last Update Posted: 2013-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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. -

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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. -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	ranibizumab	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	ranibizumab	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.
Group II	verteporfin	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.

Primary Outcome Measures

Name	Time	Method
The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

California Retina Consultants & Research Foundation; 🇺🇸 Santa Barbara, California, United States

Associated Retinal Consultants; 🇺🇸 Ann Arbor, Michigan, United States

Texas Retina Associates; 🇺🇸 Arlington, Texas, United States