Expired Study
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Phoenix, Arizona 85014


Purpose:

The objectives of this study are to evaluate the safety and tolerability of Zimura™ intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF) therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).


Study summary:

Treatment experienced (Prior treatment with anti-VEGF monotherapy of ≥8 injections in the previous twelve (12) months) subjects of either gender aged 50 years or above with a diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye) in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea® 2 mg/eye). Safety endpoints include visual acuity loss (proportion of subjects with >15 letter loss at Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3 compared to screening as measured by indocyanine green angiography (ICGA), and laboratory values.


Criteria:

Inclusion Criteria: - Subjects of either gender aged ≥ 50 years - Diagnosis of IPCV - Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8 injections in the previous twelve (12) months Exclusion Criteria: - Any intraocular surgery or thermal laser within three (3) months of trial entry - Any prior thermal laser in the macular region, regardless of indication - Any ocular or periocular infection in the twelve (12) weeks prior to entry - History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant - Previous therapeutic radiation in the region of the study eye - A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy and/or leakage from retinal vasculature in a subject with diabetes mellitus)


Study is Available At:


Original ID:

OPH2002


NCT ID:

NCT02397954


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Phase 2a 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)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

50 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ophthotech Corporation


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

4


Enrollment Type:

Actual


Study Dates

Start Date:March 2015
Completion Date:October 2015
Completion Type:Actual
Primary Completion Date:October 2015
Primary Completion Type:Actual
Verification Date:April 2017
Last Changed Date:June 18, 2019
First Received Date:March 19, 2015
First Results Date:January 2, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Participants With >15 ETDRS Letter Loss at Month 3
Time Frame:3 Months
Safety Issues:False
Description:Number of participants with >15 ETDRS letter loss (with calculated percentage)
Outcome Type:Primary Outcome
Measure:Number of Participants With Ophthalmic Adverse Events
Time Frame:3 months
Safety Issues:False
Description:Number of Participants with Ophthalmic Adverse Events (with calculated percentage)
Outcome Type:Primary Outcome
Measure:Number of Participants With Systemic Adverse Events
Time Frame:3 months
Safety Issues:False
Description:Number of Participants with Systemic Adverse Events (with calculated percentage)

Study Interventions

Intervention Type:Drug
Name:Zimura
Description:Subjects will receive monthly intravitreous injections of Zimura in combination with Lucentis, Avastin or Eylea.
Arm Name:Zimura + Anti-VEGF
Other Name:Avastin

Study Arms

Study Arm Type:Experimental
Arm Name:Zimura + Anti-VEGF
Description:Subjects will receive monthly intravitreous injections of Zimura in combination with either Lucentis, Avastin or Eylea.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Ophthotech Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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