Phase 2 N=60 Randomized Single-blind Treatment

Ranibizumab and Reduced Fluence PDT for AMD

Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT00527475 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2013

Primary outcome: Primary: The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. — 22; 14 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ranibizumab (Drug); verteporfin (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Texas Retina Associates
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.	22; 14	—
SECONDARY Percentage of Participants With Retreatments Over One Year	33; 21	—
SECONDARY Number of Injections Over 12 Months	6.8; 3.0	—
SECONDARY Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity	33; 31	—
SECONDARY Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months	91.4; 104.1	—

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.

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. -

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00527475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.