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A Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397954
Recruitment Status : Completed
First Posted : March 25, 2015
Results First Posted : January 23, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Polypoidal Choroidal Vasculopathy
Intervention Drug: Zimura
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zimura + Anti-VEGF
Hide Arm/Group Description Zimura 1mg/eye intravitreal injection + Anti-vascular endothelial growth factor (VEGF) (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Zimura + Anti-VEGF
Hide Arm/Group Description Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
74.5  (6.03)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 4 participants
Adults 50-65
0
   0.0%
Adults >65-75
2
  50.0%
Adults >75
2
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
1
  25.0%
Male
3
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Number of Participants With >15 ETDRS Letter Loss at Month 3
Hide Description Number of participants with >15 ETDRS letter loss (with calculated percentage)
Time Frame 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zimura + Anti-VEGF
Hide Arm/Group Description:
Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Number of Participants With Ophthalmic Adverse Events
Hide Description Number of Participants with Ophthalmic Adverse Events (with calculated percentage)
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zimura + Anti-VEGF
Hide Arm/Group Description:
Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
3.Primary Outcome
Title Number of Participants With Systemic Adverse Events
Hide Description Number of Participants with Systemic Adverse Events (with calculated percentage)
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zimura + Anti-VEGF
Hide Arm/Group Description:
Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
4.Other Pre-specified Outcome
Title Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3
Hide Description Mean change in central subfield retinal thickness from baseline at Month 3 as measured by SD-OCT
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Limited sample size; all study participants were included in the analysis.
Arm/Group Title Zimura + Anti-VEGF
Hide Arm/Group Description:
Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: μm
-2.75
(-67 to 69)
5.Other Pre-specified Outcome
Title Regression and/or Elimination of Polyps at Month 3
Hide Description Regression and/or Elimination of Polyps from baseline to Month 3
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zimura + Anti-VEGF
Hide Arm/Group Description:
Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Polyps
NA [1] 
[1]
Data is not available due to the limited quality of the images
Time Frame 3 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zimura + Anti-VEGF
Hide Arm/Group Description Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
All-Cause Mortality
Zimura + Anti-VEGF
Affected / at Risk (%)
Total   0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Zimura + Anti-VEGF
Affected / at Risk (%) # Events
Total   1/4 (25.00%)    
Infections and infestations   
Endophthalmitis * 1  1/4 (25.00%)  1
1
Term from vocabulary, MedDRA (11.1)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zimura + Anti-VEGF
Affected / at Risk (%) # Events
Total   3/4 (75.00%)    
Eye disorders   
Conjunctival haemorrhage * 1  3/4 (75.00%)  4
Gastrointestinal disorders   
Gastroesophageal reflux disease * 1  1/4 (25.00%)  1
1
Term from vocabulary, MedDRA (11.1)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institution agrees not to individually publish the results of the Study without Ophthotech's prior written consent. Institution may participate in a joint, multi-center publication of the Study results with other investigators and/or institutions only, upon the prior written consent of Ophthotech.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Keith Westby
Organization: Ophthotech Corp
EMail: Keith.Westby@ophthotech.com
Layout table for additonal information
Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT02397954     History of Changes
Other Study ID Numbers: OPH2002
First Submitted: March 19, 2015
First Posted: March 25, 2015
Results First Submitted: January 2, 2019
Results First Posted: January 23, 2019
Last Update Posted: June 19, 2019