Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Novartis
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

1. Age equal to or older than 50 years

2. Insufficient responder to ranibizumab Tx

3. ICGA-confirmed PCV

4. BCVA letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts

5. Ability to provide written informed consent and comply with study assessments for the full duration of the study

Exclusion Criteria:

1. Prior treatment with other anti-VEGF treatments in the study eye.

2. Prior treatment with other anti-VEGF treatments within 3 months prior to Visit 1 in the non-study eye.

3. Prior treatment with verteporfin within 6 months prior to Visit 1 in the study eye.

4. Prior treatment with verteporfin within 7 days prior to Visit 1 in the non-study eye.

5. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye

6. Previous submacular surgery in the study eye

7. A history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia

8. Experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma

9. Previous participation in a clinical trial involving anti-angiogenic drugs

10. Intraocular surgery: 2 months before Visit 1 in the study eye.

11. Previous participation in any studies of investigational drugs

12. Administration of periocular, intravitreal, or systemic corticosteroid in the previous 3 months.