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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003147-27 | EudraCT Number |
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The study hypothesis under test is that administration of the CCR2/5 antagonist has the potential to be as effective as the current treatment options for subjects with diabetic macular edema. The current treatment option for these subjects is an injection directly into the eye, while this CCR2/5 antagonist would be an oral drug which has the potential to be just as effective. This CCR2/5 antagonist also has a broader anti-inflammatory potential and might be able to provide an alternative mechanism to treat Diabetic Macular Edema.
Study recruitment was stopped on April 9, 2015. This decision was taken for business reasons due to changes in the prioritization of the drug development portfolio. This decision was not as a result of any evolving safety, efficacy issue or changes in the risk:benefit assessment of this product or regulatory interactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Intravitreal administration of ranibizumab (either 0.3 or 0.5 mg, given monthly, as detailed in the prescribing information and label content approved for the country governing the study site) plus an oral placebo. |
|
| Arm 2 | Experimental | Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Intravitreal Injection supplied as:
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA) | Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated early treatment diabetic retinopathy study (ETDRS) charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read). | Baseline (Day 0) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12 | Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated ETDRS charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read). | Baseline (Day 0) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Inclusion Criteria:
Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in the Eye
Reduced visual acuity resulting from retinal thickening
Female subjects of non-childbearing potential ≥18 years and male subjects greater than or equal to 18 years. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
Female subjects who are not of childbearing potential must meet at least one of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Research Institute, LLC | Phoenix | Arizona | 85014 | United States | ||
| Retinal Consultants of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29847672 | Derived | Gale JD, Berger B, Gilbert S, Popa S, Sultan MB, Schachar RA, Girgenti D, Perros-Huguet C. A CCR2/5 Inhibitor, PF-04634817, Is Inferior to Monthly Ranibizumab in the Treatment of Diabetic Macular Edema. Invest Ophthalmol Vis Sci. 2018 May 1;59(6):2659-2669. doi: 10.1167/iovs.17-22731. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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In total, 199 participants were randomized, with 99 randomized to receive PF 04634817 200 mg and 99 to placebo + ranibizumab 0.3/0.5 mg. One participant was randomized but discontinued prior to dosing as no longer willing to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-04634817 200 mg QD | Participants received 50 mg tablets of PF-04634817 and masked sham therapy. |
| FG001 | Placebo QD + Ranibizumab 0.3 mg | Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Oral Placebo is provided in tablet form to match the 50mg dose of PF-04634817. Dose is 4 tablets each day for 12 weeks |
|
| PF-04634817 | Drug | Four 50mg tablets PF-04634817 once a day for 12 weeks. |
|
| Masked Sham Therapy | Drug | Empty, needle-less syringe is used by the unmasked team once a month. |
|
| Mean Change From Baseline in Central Subfield Retinal Thickness in the Study Eye at Week 12 |
A central reading center was used for the evaluation. A photographer or technician pre certified ("study certified") by the Central Reading Center ought to perform all optical coherence tomography (OCT) imaging. Use of a Spectralis or Cirrus OCT was acceptable. |
| Baseline (Day 0) and Week 12 |
| Mean Change From Baseline in The Area of Fluorescein Leakage in the Study Eye at Week 12 | Fluorescein Angiography (FA) using certified digital systems was taken by a photographer who had been pre-certified ("study-certified") by the Central Reading Center. They were evaluated by the Central Reading Center. | Baseline (Day 0) and Week 12 |
| Mean Change From Baseline in Steps of Diabetic Retinopathy Step (ETDRS Severity Scale) in the Study Eye at Week 12 | Stereo color fundus photographs using certified digital systems were taken by a photographer who had been pre-certified ("study certified") by the Central Reading Center. They were evaluated by the Central Reading Center. | Baseline (Day 0) and Week 12 |
| Plasma Concentration of PF-04634817 up to Week 12 | Week 0, Week 4, Week 8, and Week 12 |
| Week 0 to Week 16 |
| Number of Participants With Potentially Clinically Important Post-Baseline Vital Signs | Number of participants who met the categorical summary of post-baseline criteria at any time point, defined as: supine pulse rate <40 beats per minute (bpm) or >120 bpm; supine systolic blood pressure (SBP) ≥30 millimeters of mercury (mmHg) change from baseline in same posture; supine diastolic BP (DBP) ≥20 mmHg change from baseline in same posture; supine SBP <90 mmHg; supine DBP <50 mmHg. | Week -5 to Week 16 |
| Number of Participants With Laboratory Abnormalities | The following laboratory parameters were analyzed for abnormalities at any time point: hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count); blood chemistry (sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase); follicle-stimulating hormone (FSH) (Weeks -5 to 0 only, for postmenopausal women who have been amenorrheic for at least 12 consecutive months prior to screening visit). | Week -5 to Week 16 |
| Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=200 msec or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QT interval >=500 msec; and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported. | Week -5 to Week 16 |
| Number of Participants With Changes in the Anterior Segment of the Study Eye at Week 12 | The anterior biomicroscopy exam was done undilated in order to assess whether there was any anterior segment inflammation caused either by ranibizumab or PF-04634817. | Week -5 to Week 16 |
| Maximum Increase of Intraocular Pressure (IOP) From Baseline in Study Eye | IOP was measured using Goldmann applanation tonometry. To maintain consistency, it was recommended that the same examiner ought to measure IOP with the same tonometer at each visit for a given subject. Intraocular pressure ought to be measured in the study eye approximately 30 minutes after intravitreal injection or masked sham therapy (performed by unmasked study team member). | Week -5 to Week 16 |
| Number of Participants With Change in Ophthalmoscopy Examination Results in Study Eye After Administration of Ranibizumab or Masked Sham Therapy at Week 8 | Ophthalmoscopy ought to be performed after pupillary dilation to examine the vitreous body, optic nerve head, macular and peripheral retina. All findings, including the presence or absence of vitreous inflammation, ought to be documented. All post-dose ophthalmoscopy assessments ought to be made immediately following the administration of ranibizumab or masked sham therapy. | Week -5 to Week 16 |
| Phoenix |
| Arizona |
| 85014 |
| United States |
| Sunny View Medical Center | Phoenix | Arizona | 85018 | United States |
| Premier Research Group Limited | Phoenix | Arizona | 85027 | United States |
| Retina Centers, P.C. | Tucson | Arizona | 85704 | United States |
| Retina Institute of California | Arcadia | California | 91007 | United States |
| Retina Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| Retinal Diagnostic Center | Campbell | California | 95008 | United States |
| Retina Associates of Orange County | Laguna Hills | California | 92653 | United States |
| Southern California Desert Retina Consultants | Palm Desert | California | 92211 | United States |
| American Institute of Research (Administrative Only) | Whittier | California | 90603 | United States |
| New England Retina Associates | New London | Connecticut | 06320 | United States |
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| Fort Lauderdale Eye Institute | Plantation | Florida | 33324 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Southeast Retina Center, PC | Augusta | Georgia | 30909 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| TLC Eyecare & Laser Center | Jackson | Michigan | 49202 | United States |
| Wm Beaumont Medical Office Building | Royal Oak | Michigan | 48073 | United States |
| Charlotte Eye Ear Nose and Throat Associates PA | Charlotte | North Carolina | 28210 | United States |
| Retina Associates of Cleveland, Inc. | Cleveland | Ohio | 44122 | United States |
| Retina Associates of Cleveland | Youngstown | Ohio | 44505 | United States |
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| University of Oklahoma -OU Physicians | Oklahoma City | Oklahoma | 73104 | United States |
| Retina Vitreous Consultants | Pittsburgh | Pennsylvania | 15213 | United States |
| Associates in Ophthalmology Ltd | West Mifflin | Pennsylvania | 15122 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Brain B.Berger,MD,PA | Austin | Texas | 78705 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Retina Consultants of Houston, PA | Houston | Texas | 77030 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Rocky Mountain Retina Consultants | Salt Lake City | Utah | 84107 | United States |
| MC Comac Medical | Sofia | 1612 | Bulgaria |
| Fakultní nemocnice Hradec Králové, Ocni klinika | Hradec Králové | 500 05 | Czechia |
| Fakultní nemocnice Hradec Králové, Nemocnicni lekarna | Hradec Králové | 50005 | Czechia |
| Fakultni nemocnice Ostrava, lekarna | Ostrava - Poruba | 70852 | Czechia |
| Fakultni nemocnice Ostrava, Ocni klinika | Ostrava - Poruba | 70852 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady, Oftalmologicka klinika | Prague | 10034 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady, Ustavni lekarna | Prague | 10034 | Czechia |
| Universitätsklinikum Regensburg | Regensburg | Bavaria | 93053 | Germany |
| Universitaetsklinikum Muenster | Münster | Germany | 48159 | Germany |
| Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Universitaetsmedizin Goettingen | Göttingen | 37075 | Germany |
| Universitatsmedizin Mainz | Mainz | 55131 | Germany |
| Augenärzte am St. Franziskus-Hospital | Münster | 48145 | Germany |
| Knappschaftsklinikum GmbH | Sulzbach | 66280 | Germany |
| Universitatsklinikum Tubingen | Tübingen | 72076 | Germany |
| Semmelweis Egyetem, Szemészeti Klinika | Budapest | 1083 | Hungary |
| Bajcsy-Zsilinszky Korhaz, Szemeszet | Budapest | 1106 | Hungary |
| Budapest Retina Associates Kft. | Budapest | 1133 | Hungary |
| Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Szemklinika | Debrecen | 4032 | Hungary |
| Ganglion Orvosi Kozpont | Pécs | 7621 | Hungary |
| Csolnoky Ferenc Korhaz, Szemeszeti Osztaly | Veszprém | 8200 | Hungary |
| Hadassah Medical Organization, Hadassah Medical Center, Ein Karem | Jerusalem | 91120 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Rabin Medical Center, Beilinson Hospital | Petah Tikva | 49100 | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Spitalul Clinic Republican | Chisinau | MD-2025 | Moldova |
| Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza Radeckiego We Wrocławiu, Klinika Okulistyki | Wroclaw | 50-367 | Poland |
| Med Life SA, Sectia Oftalmologie | Bucharest | 010719 | Romania |
| Institutul National de Diabet, Nutritie si Boli Metabolice "N.C.Paulescu" | Bucharest | 020475 | Romania |
| FG002 | Placebo QD + Ranibizumab 0.5 mg | Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-04634817 200 mg QD | Participants received 50 mg tablets of PF-04634817 and masked sham therapy. |
| BG001 | Placebo QD + Ranibizumab 0.3 mg | Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo. |
| BG002 | Placebo QD + Ranibizumab 0.5 mg | Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA) | Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated early treatment diabetic retinopathy study (ETDRS) charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read). | all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA. | Posted | Least Squares Mean | 80% Confidence Interval | Letters | Baseline (Day 0) and Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12 | Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated ETDRS charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read). | all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA. | Posted | Number | proportion of participants | Baseline (Day 0) and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Central Subfield Retinal Thickness in the Study Eye at Week 12 | A central reading center was used for the evaluation. A photographer or technician pre certified ("study certified") by the Central Reading Center ought to perform all optical coherence tomography (OCT) imaging. Use of a Spectralis or Cirrus OCT was acceptable. | all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA. | Posted | Least Squares Mean | 80% Confidence Interval | microns | Baseline (Day 0) and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in The Area of Fluorescein Leakage in the Study Eye at Week 12 | Fluorescein Angiography (FA) using certified digital systems was taken by a photographer who had been pre-certified ("study-certified") by the Central Reading Center. They were evaluated by the Central Reading Center. | all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA. | Posted | Least Squares Mean | 80% Confidence Interval | mm^2 | Baseline (Day 0) and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Steps of Diabetic Retinopathy Step (ETDRS Severity Scale) in the Study Eye at Week 12 | Stereo color fundus photographs using certified digital systems were taken by a photographer who had been pre-certified ("study certified") by the Central Reading Center. They were evaluated by the Central Reading Center. | all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA. | Posted | Least Squares Mean | 80% Confidence Interval | Letters | Baseline (Day 0) and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of PF-04634817 up to Week 12 | All subjects in the full analysis set (FAS) for whom a pharmacokinetic sample was obtained and analyzed. The FAS was defined as all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram (ng)/milliliter (mL) | Week 0, Week 4, Week 8, and Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication. | Posted | Number | participants | Week 0 to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Potentially Clinically Important Post-Baseline Vital Signs | Number of participants who met the categorical summary of post-baseline criteria at any time point, defined as: supine pulse rate <40 beats per minute (bpm) or >120 bpm; supine systolic blood pressure (SBP) ≥30 millimeters of mercury (mmHg) change from baseline in same posture; supine diastolic BP (DBP) ≥20 mmHg change from baseline in same posture; supine SBP <90 mmHg; supine DBP <50 mmHg. | The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication. | Posted | Number | participants | Week -5 to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Laboratory Abnormalities | The following laboratory parameters were analyzed for abnormalities at any time point: hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count); blood chemistry (sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase); follicle-stimulating hormone (FSH) (Weeks -5 to 0 only, for postmenopausal women who have been amenorrheic for at least 12 consecutive months prior to screening visit). | The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication. | Posted | Number | participants | Week -5 to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=200 msec or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QT interval >=500 msec; and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported. | The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication. | Posted | Number | participants | Week -5 to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Changes in the Anterior Segment of the Study Eye at Week 12 | The anterior biomicroscopy exam was done undilated in order to assess whether there was any anterior segment inflammation caused either by ranibizumab or PF-04634817. | The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication. | Posted | Number | participants | Week -5 to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Maximum Increase of Intraocular Pressure (IOP) From Baseline in Study Eye | IOP was measured using Goldmann applanation tonometry. To maintain consistency, it was recommended that the same examiner ought to measure IOP with the same tonometer at each visit for a given subject. Intraocular pressure ought to be measured in the study eye approximately 30 minutes after intravitreal injection or masked sham therapy (performed by unmasked study team member). | The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mmHg | Week -5 to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Change in Ophthalmoscopy Examination Results in Study Eye After Administration of Ranibizumab or Masked Sham Therapy at Week 8 | Ophthalmoscopy ought to be performed after pupillary dilation to examine the vitreous body, optic nerve head, macular and peripheral retina. All findings, including the presence or absence of vitreous inflammation, ought to be documented. All post-dose ophthalmoscopy assessments ought to be made immediately following the administration of ranibizumab or masked sham therapy. | The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication. | Posted | Number | participants | Week -5 to Week 16 |
|
Baseline to Week 12
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-04634817 200 mg QD | Participants received 50 mg tablets of PF-04634817 and masked sham therapy. | 7 | 99 | 17 | 99 | ||
| EG001 | Placebo QD + Ranibizumab 0.3 mg | Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo. | 2 | 43 | 15 | 43 | ||
| EG002 | Placebo QD + Ranibizumab 0.5 mg | Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo. | 3 | 56 | 7 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic valve stenosis | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Personality disorder | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diabetic retinal oedema | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| C000629947 | PF-04634817 |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
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| The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters. | Mixed Models Analysis | 0.0699 | Difference in LS means | -2.48 | Standard Error of the Mean | 1.36 | 2-Sided | 80 | -4.24 | -0.73 | Yes | Non-Inferiority or Equivalence | Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters. |
| The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters. | Mixed Models Analysis | 0.0399 | Difference in LS means | -2.41 | Standard Error of the Mean | 1.17 | 2-Sided | 80 | -3.91 | -0.91 | Yes | Non-Inferiority or Equivalence | Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters. |
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Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo. |
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Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
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Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo. |
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Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo. |
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Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo. |
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Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo. |
| OG003 | Placebo QD + Ranibizumab 0.3 mg/0.5 mg | Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo. |
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Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo. |
| OG003 | Placebo QD + Ranibizumab 0.3 mg/0.5 mg | Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo. |
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Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo. |
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| Placebo QD + Ranibizumab 0.3 mg/0.5 mg |
Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo. |
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