Phase 4
N=12
Head to Head Study of Anti-VEGF Treatment.
Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02577107 ↗Enrolled (actual)
12
Serious AEs
16.7%
Results posted
Nov 2017
Primary outcome: Primary: Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at Visit 5 (Day 8 +/- 1 Day) — 5.720; -25.833 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ranibizumab (Drug); Conbercept (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at Visit 5 (Day 8 +/- 1 Day) |
5.720; -25.833 | — |
| SECONDARY Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After Third Injection at Visit 10 (Day 67 +/- 1 Day) |
-0.100; -22.220 | — |
| SECONDARY Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection |
31.400; 42.200; 30.958; 14.920; 36.517; 24.590 | — |
| SECONDARY Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection |
36.250; 36.520; 34.383; 5.720; 46.533; 6.820 | — |
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
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed.
- Male or female patient ≥ 50 years of age.
- Subfoveal CNV secondary to nAMD.
- BCVA score must be between 73 and 24 letters as measured by ETDRS chart
Exclusion Criteria
For both eyes
- Any active periocular or ocular infection or inflammation
- Uncontrolled glaucoma
- Neovascularization of the iris or neovascular glaucoma. For study eye
- Choroidal neovascularization of any other cause than wet AMD
- Ocular disorders present that may confound interpretation of study results,
- Previous treatment with verteporfin PDT (Visudyne®), external-beam radiation therapy, focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy.
- Structural damage within 0.5 disc diameter of the center of the macula
- Atrophy or fibrosis involving the center of the fovea.
- Inability of obtaining required lab report. Ocular medical history
- History of intravitreal injection with any anti-VEGF drugs within 3 months. Exclusion criteria for systemic medical conditions and treatment
- Any type of systemic disease or its treatment
- Any patients diagnosed with tumor.
- Stroke or myocardial infarction less than 3 months.
- Known hypersensitivity to indocyanine green, fluorescein, or any component of the investigational drug formulation.
- Use of any systemic anti-VEGF drugs within 6 months. Exclusion criteria for patient
- Patients who have participated in other investigational drug study within 60 days.
- Pregnant or nursing (lactating) women.
- Inability to comply with study or follow-up procedures.
Data sourced from ClinicalTrials.gov (NCT02577107). 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.