Head to Head Study of Anti-VEGF Treatment.

• Status: Completed
• Trial end date: 2016-07-09
• Target enrollment: 0
• Participant gender: All

Summary

An exploratory single site, open label, randomized, controlled study evaluated plasma vascular endothelial growth factor levels after intravitreal injection of ranibizumab (Lucentis) and conbercept (Langmu) for neovascular age-related macular degeneration

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Bevacizumab; Endothelial Growth Factors; Ranibizumab

Criteria

Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.

2. Male or female patient ≥ 50 years of age.

3. Subfoveal CNV secondary to nAMD.

4. BCVA score must be between 73 and 24 letters as measured by ETDRS chart

Exclusion Criteria:

For both eyes

1. Any active periocular or ocular infection or inflammation

2. Uncontrolled glaucoma

3. Neovascularization of the iris or neovascular glaucoma. For study eye

4. Choroidal neovascularization of any other cause than wet AMD

5. Ocular disorders present that may confound interpretation of study results,

6. Previous treatment with verteporfin PDT (Visudyne®), external-beam radiation therapy, focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy.

7. Structural damage within 0.5 disc diameter of the center of the macula

8. Atrophy or fibrosis involving the center of the fovea.

9. Inability of obtaining required lab report. Ocular medical history

10. History of intravitreal injection with any anti-VEGF drugs within 3 months. Exclusion criteria for systemic medical conditions and treatment

11. Any type of systemic disease or its treatment

12. Any patients diagnosed with tumor.

13. Stroke or myocardial infarction less than 3 months.

14. Known hypersensitivity to indocyanine green, fluorescein, or any component of the investigational drug formulation.

15. Use of any systemic anti-VEGF drugs within 6 months. Exclusion criteria for patient

16. Patients who have participated in other investigational drug study within 60 days.

17. Pregnant or nursing (lactating) women.

18. Inability to comply with study or follow-up procedures.