A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration

Macular Degeneration Clinical Trial

Official title:

A Multiple-Center, Non-Randomized, Open-Label, Single- and Multiple-Ascending-Dose, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6867461 Following Intravitreal Administration in Patients With Wet Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941082
• Other study ID #: BP28936
• Secondary ID: 2013-001972-40
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2013
• Last updated: November 1, 2016
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This multicenter, non-randomized, open-label, single- and multiple-ascending-dose study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6867461 in patients with wet age-related macular degeneration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 50 years of age

• Patients with age-related macular degeneration (AMD)

• Best corrected visual acuity (BCVA) of 20/40 to 20/400 (Snellen equivalent, on ETDRA charts) inclusive

• Evidence of leakage due to choroidal neovascularization (CNV)

Exclusion Criteria:

• Choroidal neovascularization (CNV) in either eye due to causes other than age related macular degeneration, such as ocular histoplasmosis, trauma, or pathologic myopia

• Known hypersensitivity to ranibizumab, fluorescein, indocyanin green (ICG) or any of the ingredients of the formulation used, or any of the medications used

• Any other restriction according to the use of ranibizumab

• Active intraocular inflammation (grade trace or above) in the study eye

• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• RO6867461
Single or multiple ascending dose by intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular safety, assessed by BCVA (EDTRS chart), slitlamp examination, ophthalmoscopy, IOP, fundus photography, SD-OCT, angiography		Part A, 12 weeks; Part B, 20 weeks	Yes
Primary	Safety: Incidence of adverse events		Part A, 12 weeks; Part B, 20 weeks	No
Secondary	Pharmacokinetics: Area under the concentration time curve (AUC)		Part A, 12 weeks; Part B, 20 weeks	No
Secondary	Pharmacokinetics: Maximum plasma concentration (Cmax)		Part A, 12 weeks; Part B, 20 weeks	No