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A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

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: NCT01944839
Recruitment Status : Terminated
First Posted : September 18, 2013
Results First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ophthotech ( Ophthotech Corporation )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Age-Related Macular Degeneration
Interventions Drug: E10030
Drug: ranibizumab
Drug: E10030 sham intravitreal injection
Enrollment 619
Recruitment Details  
Pre-assignment Details  
Arm/Group Title E10030 + Ranibizumab Sham + Ranibizumab
Hide Arm/Group Description

E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection

E10030

ranibizumab

E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection

ranibizumab

E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle

Period Title: Overall Study
Started 309 310
Completed 287 282
Not Completed 22 28
Reason Not Completed
Physician Decision             2             2
Protocol Violation             0             1
Adverse Event             10             5
Withdrawal by Subject             9             17
Lost to Follow-up             1             0
Subject non-compliance             0             3
Arm/Group Title E10030 + Ranibizumab Sham + Ranibizumab Total
Hide Arm/Group Description

E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection

E10030

ranibizumab

E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection

ranibizumab

E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle

Total of all reporting groups
Overall Number of Baseline Participants 309 310 619
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 309 participants 310 participants 619 participants
76.1  (7.98) 76.9  (8.04) NA [1]   (NA)
[1]
not calculated
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 309 participants 310 participants 619 participants
Adults 18-64 years
26
   8.4%
20
   6.5%
46
   7.4%
Adults 65 - 84 years
243
  78.6%
233
  75.2%
476
  76.9%
85 years and over
40
  12.9%
57
  18.4%
97
  15.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 309 participants 310 participants 619 participants
Female
181
  58.6%
196
  63.2%
377
  60.9%
Male
128
  41.4%
114
  36.8%
242
  39.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 309 participants 310 participants 619 participants
United States
106
  34.3%
104
  33.5%
210
  33.9%
Czechia
42
  13.6%
42
  13.5%
84
  13.6%
United Kingdom
13
   4.2%
14
   4.5%
27
   4.4%
Switzerland
3
   1.0%
4
   1.3%
7
   1.1%
Canada
14
   4.5%
9
   2.9%
23
   3.7%
Austria
5
   1.6%
5
   1.6%
10
   1.6%
Latvia
21
   6.8%
25
   8.1%
46
   7.4%
Belgium
1
   0.3%
0
   0.0%
1
   0.2%
Poland
23
   7.4%
23
   7.4%
46
   7.4%
Brazil
8
   2.6%
8
   2.6%
16
   2.6%
Italy
56
  18.1%
62
  20.0%
118
  19.1%
Slovakia
5
   1.6%
4
   1.3%
9
   1.5%
Estonia
12
   3.9%
10
   3.2%
22
   3.6%
1.Primary Outcome
Title Mean Change in Visual Acuity From Baseline to 12 Months
Hide Description The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title E10030 + Ranibizumab Sham + Ranibizumab
Hide Arm/Group Description:

E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection

E10030

ranibizumab

E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection

ranibizumab

E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle

Overall Number of Participants Analyzed 309 310
Mean (Standard Error)
Unit of Measure: letters
10.74  (0.86) 9.82  (0.86)
Time Frame Up to 12 months of exposure
Adverse Event Reporting Description The efficacy (ITT) population, defined as all subjects randomized and received at least one dose of study drug, is different than the safety population, where all subjects who have received at least one dose of E10030 are analyzed as on that group. There was one subject who was randomized to Sham+Ranibizumab but was mis-treated with one dose of E10030 and therefore was analyzed in the E10030+ranibizuma group for safety purposes. This is the same explanation for the SAE and Mortality tables.
 
Arm/Group Title E10030 + Ranibizumab Sham + Ranibizumab
Hide Arm/Group Description

E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection

E10030

ranibizumab

E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection

ranibizumab

E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle

All-Cause Mortality
E10030 + Ranibizumab Sham + Ranibizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   6/310 (1.94%)      2/309 (0.65%)    
Hide Serious Adverse Events
E10030 + Ranibizumab Sham + Ranibizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/310 (15.48%)      36/309 (11.65%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Cardiac disorders     
Atrial fibrillation * 1  3/310 (0.97%)  3 3/309 (0.97%)  3
Atrial flutter * 1  2/310 (0.65%)  2 1/309 (0.32%)  1
Acute coronary syndrome * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Acute myocardial infarction * 1  1/310 (0.32%)  1 2/309 (0.65%)  2
Angina unstable * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Arrhythmia * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Cardiac arrest * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Cardiac failure * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Cardiac failure congestive * 1  1/310 (0.32%)  1 1/309 (0.32%)  1
Cardiac fibrillation * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Conduction disorder * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Coronary artery disease * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Cardiogenic shock * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Myocardial infarction * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Eye disorders     
Cataract * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Cataract subcapsular * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Retinal tear * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Vitreous haemorrhage * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Macular hole * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Visual acuity reduced * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Gastrointestinal disorders     
Gastrointestinal haemorrhage * 1  3/310 (0.97%)  3 0/309 (0.00%)  0
Abdominal pain * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Colitis * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Diverticular perforation * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Diverticulum * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Colitis ischaemic * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Diarrhoea haemorrhagic * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Large intestine perforation * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Oesophageal varices haemorrhage * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Oroantral fistula * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Small intestinal obstruction * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
General disorders     
Device malfunction * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Device failure * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Infections and infestations     
Pneumonia * 1  4/310 (1.29%)  4 1/309 (0.32%)  1
Endophthalmitis * 1  3/310 (0.97%)  3 0/309 (0.00%)  0
Abdominal abscess * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Gastroenteritis * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Herpes zoster meningoencephalitis * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Infective exacerbation of chronic obstructive airways disease * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Pneumonia influenzal * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Pneumonia respiratory syncytial viral * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Urinary tract infection * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Urinary tract infection bacterial * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Bronchitis * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Diverticulitis * 1  0/310 (0.00%)  0 2/309 (0.65%)  2
Erysipelas * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Infected skin ulcer * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Sepsis * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Sinusitis * 1  0/310 (0.00%)  0 2/309 (0.65%)  2
Wound infection * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Injury, poisoning and procedural complications     
Face injury * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Fall * 1  1/310 (0.32%)  1 1/309 (0.32%)  1
Ankle fracture * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Fractured sacrum * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Hip fracture * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Humerus fracture * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Intestinal anastomosis complication * 1  0/310 (0.00%)  0 1/309 (0.32%)  3
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  2/310 (0.65%)  2 0/309 (0.00%)  0
Spinal column stenosis * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Bone infarction * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder neoplasm * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Bladder transitional cell carcinoma * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Prostate cancer * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Rectal cancer * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Renal cell carcinoma * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Adenocarcinoma gastric * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Colon cancer * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Gilioma * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Meningioma * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Myxofibrosarcoma * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Non-small cell lung cancer * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Nervous system disorders     
Syncope * 1  2/310 (0.65%)  2 0/309 (0.00%)  0
Cerebral infarction * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Haemorrhagic stroke * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Transient ischaemic attack * 1  1/310 (0.32%)  1 1/309 (0.32%)  1
Cerebral haemorrhage * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Epilepsy * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Subarachnoidal haemorrhage * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
VIIth nerve paralysis * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Ischaemic stroke * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Psychiatric disorders     
Depression * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Major depression * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury * 1  1/310 (0.32%)  1 1/309 (0.32%)  1
Ureteric rupture * 1  1/310 (0.32%)  1 0/309 (0.00%)  0
Haematuria * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  3/310 (0.97%)  3 0/309 (0.00%)  0
Pneumothorax * 1  2/310 (0.65%)  2 0/309 (0.00%)  0
Acute respiratory failure * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Asthma * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Pneumonia aspiration * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Skin and subcutaneous tissue disorders     
Skin ulcer * 1  1/310 (0.32%)  2 0/309 (0.00%)  0
Vascular disorders     
Aortic aneurysm * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Aortic stenosis * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Deep vein thrombosis * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Hypertensive crisis * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Peripheral arterial occlusive disease * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
Thrombophlebitis superficial * 1  0/310 (0.00%)  0 1/309 (0.32%)  1
1
Term from vocabulary, MedDRA 18.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E10030 + Ranibizumab Sham + Ranibizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   123/310 (39.68%)      114/309 (36.89%)    
Eye disorders     
Conjunctival haemorrhage * 1  60/310 (19.35%)  197 56/309 (18.12%)  177
Eye pain * 1  23/310 (7.42%)  29 26/309 (8.41%)  47
Punctate keratitis * 1  15/310 (4.84%)  22 18/309 (5.83%)  30
Infections and infestations     
Nasopharyngitis * 1  19/310 (6.13%)  20 6/309 (1.94%)  6
Investigations     
Intraocular pressure increased * 1  43/310 (13.87%)  157 30/309 (9.71%)  78
1
Term from vocabulary, MedDRA 18.1
*
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: Denise Teuber
Organization: Ophthotech
EMail: denise.teuber@ophthotech.com
Layout table for additonal information
Responsible Party: Ophthotech ( Ophthotech Corporation )
ClinicalTrials.gov Identifier: NCT01944839    
Other Study ID Numbers: OPH1002
First Submitted: September 9, 2013
First Posted: September 18, 2013
Results First Submitted: July 11, 2018
Results First Posted: August 10, 2018
Last Update Posted: August 10, 2018