A 12-month randomized, double-masked, multicenter, phase II study assessing safety and efficacy of Visudyne photodynamic therapy administered in conjunction with Lucentis versus Lucentis monotherapy in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneratio

Phase 2

• Conditions: macular degeneration; subfoveal choroidal neovascularization secondary to age-related macular degeneration; 10047060

• Registration Number: NL-OMON31180
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Protocol page 17
- Male or female patients of any race 50 years or older
- Presence of primary active subfoveal CNV secondary to AMD
- Total CNV area more than or equal to 50% of the total lesion area
- Total lesion area must be less than or equal to 5400 microns
- BCVA letter score in study eye between 24 and 73 letters using ETDRS chart at 4 meters distance
- Written and informed consent
- Patients willing and able to comply with study procedures

Exclusion Criteria

Protocol page 17, 18 and 19
- Presence of CNV secondary to causes other than AMD
- Presence of hypofluorescent lesions other than CNV greater than 50% of total lesion
- Tear of the retinal pigment epithelium
- Ocular inflammation or infection within 30 days prior to randomization
- Uncontrolled glaucoma
- Prior treatment for neovascular AMD
- History of intraocular surgery
- Hypersensitivity to components of study drugs
- Use of medication that could induce photosensitivity
- Unable to obtain results from study assessments

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Results Best Corrected Visual Acuity test month 12 compared to baseline<br /><br>- Treatment free interval of at least three months duration at any timepoint<br /><br>following Month 2</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Number of Lucentis retreatments administered over 9 months following the<br /><br>Month 2 treatment<br /><br>- Time to first retreatment with Lucentis following month 2.<br /><br>- Eye assessments, vital signs and adverse events<br /><br>- Changes in OCT and angiogram outcomes over 12 months<br /><br>- Mean change in best corrected visual acuity at month 1, 2 and 3 </p><br>