RAP: Ranibizumab and Reduced Fluence PDT for AMD

• Sponsor: Texas Retina Associates (Other)
• Overall Status: Completed
• CT.gov ID: NCT00527475
• Collaborator: Novartis (Industry)
• Enrollment: 60
• Locations: 3
• Arms: 2
• Duration (Months): 32.1
• Patients Per Site: 20
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Drug: ranibizumab; Drug: verteporfin	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group I 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.	Drug: ranibizumab; 0.5 mg. given as an intraocular injection
Experimental: Group II 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.	Drug: ranibizumab; 0.5 mg. given as an intraocular injection; Drug: verteporfin; Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.

Outcome Measures

Primary Outcome Measures

1. The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. [1 year]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

6. Recent loss of vision (5 letters on ETDRS or doubling of visual angle by snellen)

7. Documented enlargement of lesion on FA

8. Increase of 50 microns or more in the central subfield on OCT

9. New blood

10. 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. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Retina Consultants & Research Foundation	Santa Barbara	California	United States	93103
2	Associated Retinal Consultants	Ann Arbor	Michigan	United States	49301
3	Texas Retina Associates	Arlington	Texas	United States	76012

Sponsors and Collaborators

• Texas Retina Associates
• Novartis

Investigators

• Study Chair: David Callanan, MD, Texas Retina Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Texas Retina Associates
• ClinicalTrials.gov Identifier: NCT00527475
• Other Study ID Numbers: RAP AMD Trial
• First Posted: Sep 11, 2007
• Last Update Posted: Jun 7, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Texas Retina Associates: Anti-VEGF therapy; photodynamic therapy; neovascularization
• Additional relevant MeSH terms: Macular Degeneration; Ranibizumab; Verteporfin

Study Results

Participant Flow

Arm/Group Title	Ranibizumab	Reduced Fluence PDT & Ranibizumab
Arm/Group 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.
Period Title: Overall Study
STARTED	30	30
COMPLETED	27	29
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Group I	Group II	Total
Arm/Group 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.	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	79.1 (8.35)	79.3 (7.23)	79.2 (7.72)
Sex: Female, Male (Count of Participants)
Female	14 46.7%	18 60%	32 53.3%
Male	16 53.3%	12 40%	28 46.7%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Fifty-six participants completed the full 12 month study. Four subjects did not return for the 12 month visit. No patients terminated the study due to adverse events.

Arm/Group Title	Group I	Group II
Arm/Group 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.
Measure Participants	27	29
Number [percentage of participants]	22 73.3%	14 46.7%

2. Secondary Outcome

Title	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Group I		Group II
Arm/Group 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.
All Cause Mortality
	Group I		Group II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group I		Group II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Group I		Group II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.