Phase 1
N=31
Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration
Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01835015 ↗Enrolled (actual)
31
Serious AEs
2.5%
Results posted
Mar 2016
Primary outcome: Primary: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye — 23.7; 25.7; 27.6; 41.5 letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- CLG561 (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye |
23.7; 25.7; 27.6; 41.5; 38.0; 0.7 | — |
| PRIMARY Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye |
14.7; 14.3; 15.7; 15.2; 16.5; 16.3 | — |
| PRIMARY Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment |
5; 4; 4; 6; 5; 1 | — |
| PRIMARY Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment |
5; 4; 5; 6; 6; 0 | — |
| SECONDARY Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)] |
NA; NA; NA; 238000; 373000 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)] |
NA; NA; NA; 195000; 304000 | — |
| SECONDARY Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax) |
NA; NA; NA; 144; 187 | — |
| SECONDARY Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D) |
NA; NA; NA; 102; 75.8 | — |
| SECONDARY Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D] |
NA; NA; NA; 38900; 30400 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Time Zero to Time "t" Where t is a Defined Time Point After Administration [AUC(0-t)] |
— | — |
| SECONDARY Terminal Elimination Half-life (T½) |
— | — |
| SECONDARY The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) |
— | — |
| SECONDARY Apparent Systemic (or Total Body) Clearance From Serum Following Extravascular Administration (CL/F) |
— | — |
Summary
The purpose of this study is to evaluate the safety, tolerability, and serum pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration (AMD).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of age-related macular degeneration in study eye, as specified in protocol.
- Poor visual acuity in study eye, as specified in protocol.
- Willing to receive meningitis and pneumonia vaccinations at least 2 weeks prior to study treatment.
- Females must be post-menopausal and/or surgically sterile.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Treatments to the study eye within 28 days prior to study treatment, as specified in protocol.
- Any disease or medication expected to cause systemic or ocular immunosuppression.
- Participation in another interventional clinical study or use of any experimental treatment for AMD within 12 weeks prior to study treatment.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01835015). 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.