search
Back to results

ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)

Primary Purpose

Wet Age-related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zimura
Lucentis
Sponsored by
Ophthotech Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Age-related Macular Degeneration focused on measuring Zimura, ARC1905, Lucentis, ranibizumab, Wet AMD, avacincaptad pegol, complement factor C5 inhibitor

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Active subfoveal NVAMD

Exclusion Criteria:

  • History or evidence of severe cardiac disease
  • Any major surgical procedure within one month of trial entry
  • Subjects with a clinically significant laboratory value
  • Any treatment with an investigational agent in the past 60 days for any condition
  • Women who are pregnant or nursing
  • Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation
  • Any prior treatment for AMD other than oral supplements of vitamins and minerals

Sites / Locations

  • Retinal Research Institute
  • Retina Centers PC
  • Retina Associates SW, PC
  • Retina-Vitreous Associates Medical Group
  • Retina Consultants of Orange County
  • Retina Consultants of Southern California
  • Retinal Consultants Medical Group
  • Orange County Retina Medical Group
  • Colorado Retina Associates
  • Florida Eye Clinic
  • Florida Eye Associates
  • Illinois Eye Center
  • Vitreo Retinal Consultants & Surgeons
  • Ophthalmic Consultants of Boston
  • VitreoRetinal Surgery
  • Retina Consultants of Nevada
  • Sierra Eye Associates
  • Retina Vitreous Surgeons of CNY, PC
  • Retina Northwest PC
  • Mid Atlantic Retina
  • Charleston Neuroscience Institute
  • Retina Research Institute of Texas
  • Strategic Clinical Research Group
  • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
  • Budapest Retina Associates
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika
  • Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology
  • Dr. Solomatin's eye rehabilitation and vision correction centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

Zimura dosage 1 + Lucentis 0.5 mg

Zimura dosage 2 + Lucentis 0.5 mg

Zimura dosage 3 + Lucentis 0.5 mg

Zimura dosage 4 + Lucentis 0.5 mg

Outcomes

Primary Outcome Measures

Systemic Adverse Events
Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)
Ophthalmic Adverse Events
Number of participants with ophthalmic Adverse Events (with calculated percentage)

Secondary Outcome Measures

Full Information

First Posted
October 30, 2017
Last Updated
February 3, 2022
Sponsor
Ophthotech Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT03362190
Brief Title
ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)
Official Title
A Phase 2A Open-label Trial to Assess the Safety of ZIMURA™ (Anti-C5) Administered in Combination With LUCENTIS® 0.5 mg in Treatment Naive Subjects With Neovascular Age Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
October 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophthotech Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Age-related Macular Degeneration
Keywords
Zimura, ARC1905, Lucentis, ranibizumab, Wet AMD, avacincaptad pegol, complement factor C5 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Zimura dosage 1 + Lucentis 0.5 mg
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Zimura dosage 2 + Lucentis 0.5 mg
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Zimura dosage 3 + Lucentis 0.5 mg
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Zimura dosage 4 + Lucentis 0.5 mg
Intervention Type
Drug
Intervention Name(s)
Zimura
Other Intervention Name(s)
avacincaptad pegol
Intervention Description
Zimura in combination with Lucentis
Intervention Type
Drug
Intervention Name(s)
Lucentis
Other Intervention Name(s)
ranibizumab
Intervention Description
Zimura in combination with Lucentis
Primary Outcome Measure Information:
Title
Systemic Adverse Events
Description
Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)
Time Frame
6 months
Title
Ophthalmic Adverse Events
Description
Number of participants with ophthalmic Adverse Events (with calculated percentage)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change From Baseline - ECG
Description
Number of patients with a change on their Month 6 ECG when compared to their baseline ECG
Time Frame
6 months
Title
Mean Change From Baseline - Study Eye ETDRS Visual Acuity
Description
Mean change from Baseline to Month 6 in the number of letters read by the study eye using the ETDRS Visual Acuity charts. Higher ETDRS letters represents better vision and a larger change in ETDRS letters represents better functioning.
Time Frame
6 months
Title
Mean Change From Baseline - Vital Signs
Description
Mean change from Baseline to Month 6 in blood pressure (mm Hg). A negative number indicates a decrease and a positive number indicates an increase.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active subfoveal NVAMD Exclusion Criteria: History or evidence of severe cardiac disease Any major surgical procedure within one month of trial entry Subjects with a clinically significant laboratory value Any treatment with an investigational agent in the past 60 days for any condition Women who are pregnant or nursing Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation Any prior treatment for AMD other than oral supplements of vitamins and minerals
Facility Information:
Facility Name
Retinal Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Retina Centers PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Retina Associates SW, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Retina Consultants of Southern California
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Retinal Consultants Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
Country
United States
Facility Name
Orange County Retina Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Colorado Retina Associates
City
Golden
State/Province
Colorado
ZIP/Postal Code
80214
Country
United States
Facility Name
Florida Eye Clinic
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Illinois Eye Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Vitreo Retinal Consultants & Surgeons
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
VitreoRetinal Surgery
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Retina Consultants of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Retina Vitreous Surgeons of CNY, PC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
Retina Northwest PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97221
Country
United States
Facility Name
Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Charleston Neuroscience Institute
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Strategic Clinical Research Group
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Budapest Retina Associates
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika
City
Szeged
ZIP/Postal Code
6702
Country
Hungary
Facility Name
Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Dr. Solomatin's eye rehabilitation and vision correction centre
City
Riga
ZIP/Postal Code
LV-1050
Country
Latvia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data at this time.

Learn more about this trial

ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)

We'll reach out to this number within 24 hrs