Phase 4
Completed N=12
Head to Head Study of Anti-VEGF Treatment.
Source: ClinicalTrials.gov NCT02577107 ↗Enrolled (actual)
12
Serious AEs
16.7%
Results posted
Nov 2017
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
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 | — |
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. Informational only — not medical advice.