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

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ClinicalTrials.gov Identifier: NCT01940900
Recruitment Status : Terminated
First Posted : September 12, 2013
Results First Posted : August 15, 2018
Last Update Posted : August 15, 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 627
Recruitment Details 627 patients were randomized but 1 patient was not treated
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 311 315
Completed 282 284
Not Completed 29 31
Reason Not Completed
Physician Decision             4             0
Adverse Event             10             15
Withdrawal by Subject             11             15
Lost to Follow-up             1             0
Sponsor Decision             1             0
subject non-compliance             1             1
other             1             0
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 311 315 626
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 311 participants 315 participants 626 participants
Adults 18-64 years 30 31 61
Adults 65-84 years 224 221 445
Adults 85 years and over 57 63 120
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 311 participants 315 participants 626 participants
Female
178
  57.2%
189
  60.0%
367
  58.6%
Male
133
  42.8%
126
  40.0%
259
  41.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 311 participants 315 participants 626 participants
Colombia 11 9 20
Argentina 21 15 36
Turkey 3 4 7
Hungary 58 61 119
United States 100 97 197
Denmark 11 12 23
Israel 34 31 65
Australia 4 9 13
France 49 55 104
Germany 8 9 17
Spain 12 13 25
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
Mean change in visual acuity (ETDRS letter) from Baseline to Month 12
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 311 315
Mean (Standard Error)
Unit of Measure: letters
9.91  (0.88) 10.36  (0.87)
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   4/312 (1.28%)      4/314 (1.27%)    
Hide Serious Adverse Events
E10030 + Ranibizumab Sham + Ranibizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/312 (17.95%)      49/314 (15.61%)    
Blood and lymphatic system disorders     
Anaemia * 1  0/312 (0.00%)  0 2/314 (0.64%)  4
Cardiac disorders     
Atrial fibrillation * 1  3/312 (0.96%)  4 1/314 (0.32%)  1
Acute myocardial infarction * 1  0/312 (0.00%)  0 3/314 (0.96%)  4
Angina pectoris * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Atrioventricular block complete * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Bradycardia * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Cardiac failure * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Heart valve incompetence * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Myocardial ischaemia * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Sinus node dysfunction * 1  1/312 (0.32%)  1 1/314 (0.32%)  1
Ventricular tachycardia * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Endocrine disorders     
Goitre * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Eye disorders     
Macular hole * 1  3/312 (0.96%)  3 0/314 (0.00%)  0
Optic ischaemic neuropathy * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Retinal detachment * 1  3/312 (0.96%)  4 0/314 (0.00%)  0
Retinal haemorrhage * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Retinal pigment epithelial tear * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Vitreous haemorrhage * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Gastrointestinal disorders     
Abdominal wall haematoma * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Gastrointestinal haemorrhage * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Haemorrhoidal haemorrhage * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Inguinal hernia strangulated * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Peptic ulcer * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Rectal prolapse * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
General disorders     
Asthenia * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Chest pain * 1  1/312 (0.32%)  3 0/314 (0.00%)  0
Device malfunction * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis chronic * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Infections and infestations     
Aspergillus infection * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Bronchitis * 1  1/312 (0.32%)  2 0/314 (0.00%)  0
Cellulitis * 1  1/312 (0.32%)  1 1/314 (0.32%)  1
Chlostridium difficile colitis * 1  0/312 (0.00%)  0 1/314 (0.32%)  2
Device related sepsis * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Diverticulitis * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Endophthalmitis * 1  6/312 (1.92%)  6 2/314 (0.64%)  2
Gastroenteritis * 1  1/312 (0.32%)  1 1/314 (0.32%)  1
Gastrointestinal infection * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Infectious colitis * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Pneumonia * 1  0/312 (0.00%)  0 2/314 (0.64%)  2
Pneumonia staphylococcal * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Pyelonephritis * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Skin infection * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Urinary tract infection * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Vestibular neuronitis * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Urinary tract infection enterococcal * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Injury, poisoning and procedural complications     
Cataract traumatic * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Compression fracture * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Fall * 1  3/312 (0.96%)  3 2/314 (0.64%)  2
Femoral neck fracture * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Femur fracture * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Hip fracture * 1  1/312 (0.32%)  1 3/314 (0.96%)  3
Limb injury * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Lumbar vertebral fracture * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Periprosthetic fracture * 1  1/312 (0.32%)  1 1/314 (0.32%)  1
Rib fracture * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Splenic rupture * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Thoracic vertebral fracture * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Upper limb fracture * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Wrist fracture * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Subdural haematoma * 1  1/312 (0.32%)  1 1/314 (0.32%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Lumbar spinal stenosis * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Osteoarthritis * 1  1/312 (0.32%)  1 1/314 (0.32%)  1
Spinal osteoarthritis * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Diffuse large B-cell lymphoma * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Follicle centre, lymphoma, follicular grade I, II, III stage IV * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Invasive ductal breast carcinoma * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Leukaemia * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Lung adenocarcinoma * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Lung carcinoma cell type unspecified stage I * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Lung neoplasm malignant * 1  2/312 (0.64%)  3 3/314 (0.96%)  3
Lung squamous cell carcinoma stage III * 1  1/312 (0.32%)  2 0/314 (0.00%)  0
Metastases to central nervous system * 1  3/312 (0.96%)  3 0/314 (0.00%)  0
Metastases to bone * 1  1/312 (0.32%)  2 0/314 (0.00%)  0
Metastases to liver * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Metastatic neoplasm * 1  1/312 (0.32%)  2 0/314 (0.00%)  0
Non-small cell lung cancer * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Oesophageal carcinoma * 1  1/312 (0.32%)  2 0/314 (0.00%)  0
Prostate cancer * 1  1/312 (0.32%)  1 2/314 (0.64%)  2
Squamous cell carcinoma of lung * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Breast cancer recurrent * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Malignant melanoma stage III * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Nervous system disorders     
Cerebral infarction * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Ischaemic stroke * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Syncope * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Transient ischaemic attack * 1  2/312 (0.64%)  2 0/314 (0.00%)  0
Hepatic encephalopathy * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Renal and urinary disorders     
Renal cyst * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Renal failure * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Urethral stenosis * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Urinary bladder polyp * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchiectasis * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Chronic obstructive pulmonary disease * 1  3/312 (0.96%)  3 0/314 (0.00%)  0
Dyspnoea * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Pleural effusion * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Pulmonary oedema * 1  1/312 (0.32%)  1 1/314 (0.32%)  2
Vascular disorders     
Accelerated hypertension * 1  1/312 (0.32%)  1 0/314 (0.00%)  0
Hypertension * 1  0/312 (0.00%)  0 1/314 (0.32%)  1
Hypertensive crisis * 1  2/312 (0.64%)  2 0/314 (0.00%)  0
1
Term from vocabulary, MedDR 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   161/312 (51.60%)      136/314 (43.31%)    
Eye disorders     
Conjunctival haemorrhage * 1  74/312 (23.72%)  166 50/314 (15.92%)  136
Punctate keratitis * 1  35/312 (11.22%)  93 40/314 (12.74%)  97
Conjuctival hyperaemia * 1  24/312 (7.69%)  48 24/314 (7.64%)  53
Eye pain * 1  22/312 (7.05%)  51 21/314 (6.69%)  35
Vitreous floaters * 1  22/312 (7.05%)  28 12/314 (3.82%)  13
Eye irritation * 1  18/312 (5.77%)  34 15/314 (4.78%)  35
Keratitis * 1  18/312 (5.77%)  64 14/314 (4.46%)  47
Infections and infestations     
Nasopharyngitis * 1  17/312 (5.45%)  18 18/314 (5.73%)  20
Urinary tract infection * 1  17/312 (5.45%)  23 18/314 (5.73%)  25
Bronchitis * 1  16/312 (5.13%)  18 11/314 (3.50%)  12
Investigations     
Intraocular pressure increased * 1  49/312 (15.71%)  101 25/314 (7.96%)  42
1
Term from vocabulary, MedDR 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 Corp.
EMail: denise.teuber@ophthotech.com
Layout table for additonal information
Responsible Party: Ophthotech ( Ophthotech Corporation )
ClinicalTrials.gov Identifier: NCT01940900    
Other Study ID Numbers: OPH1003
First Submitted: September 9, 2013
First Posted: September 12, 2013
Results First Submitted: July 11, 2018
Results First Posted: August 15, 2018
Last Update Posted: August 15, 2018