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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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This study will examine the use of Aflibercept in patients with exudative macular degeneration requiring intravitreal injections. Patients will be followed for 24 months. The follow up phase will be completed at month 36.
The purpose of this study is to examine the use of Aflibercept in patients who have been previously treated with Ranibizumab or Bevacizumab for exudative macular degeneration. Specifically, we will examine its effect on macular degeneration, measured by SDOCT (Spectral Domain Optical Coherence Tomography) and ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity. This will be a prospective study with patients to receive an intravitreal injection of Aflibercept at the time of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Aflibercept | Experimental | Subjects were given 2 mg (0.05 mL) of intravitreal aflibercept injection administered every month for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label for the next 9 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Patients received 2 mg (0.05 mL) of intravitreal aflibercept injection administered monthly for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label for the next 9 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Central Subfield Thickness From Baseline at 12 Months | The mean absolute change from baseline central subfield thickness at 12 months as measured by SDOCT | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best-corrected Visual Acuity From Baseline at 12 Months | The mean absolute change from baseline in best-corrected visual acuity score at 12 months as measured by Eletronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) protocol. There were no sub scales used. These are common methods for ophthalmology studies to report their findings. The scale provided is the Electronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) best corrected visual acuity scale. Values that are higher are considered better and values that are lower are considered worse. Minimum E-ETDRS was 24 E-ETDRS letters and maximum E-ETDRS was 80 E-ETDRS letters. |
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Inclusion Criteria
A subject must meet the following criteria to be eligible for inclusion in the study:
Signed Informed Consent.
Men and women ≥ 50 years of age.
Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by historical optical coherence tomographies (OCTs) and angiograms in the study eye.
CNV must be at least 50% of total lesion size by either previous or current angiogram.
ETDRS best-corrected visual acuity of: 20/25 to 20/320 (letter score of 73 to 25) in the study eye.
Willing, committed, and able to return for all clinic visits and complete all study related procedures.
At least one injection of Ranibizumab or Bevacizumab within 3 months of enrollment for active exudative AMD.
Active need for anti- vascular endothelial growth factor (anti-VEGF) therapy at study entry based on the following criteria:
Exclusion Criteria
A subject who meets any of the following criteria will be excluded from the study:
Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
Prior systemic anti-VEGF therapy, investigational or FDA/Health Canada approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study.
Presence of retinal pigment epithelial tears or rips involving the macula in the study
History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
Presence of other causes of CNV, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye.
History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
Prior vitrectomy in the study eye.
History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
Any history of macular hole of stage 2 and above in the study eye.
Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it's unlikely to interfere with the injection.
Prior trabeculectomy or other filtration surgery in the study eye.
Uncontrolled glaucoma at baseline evaluation (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
Active intraocular inflammation in either eye.
Active ocular or periocular infection in either eye.
Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
Any history of uveitis in either eye.
Active scleritis or episcleritis in either eye.
Presence or history of scleromalacia in either eye.
Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye.
Previous therapeutic radiation in the region of the study eye.
History of corneal transplant or corneal dystrophy in the study eye.
Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of safety, or fundus photography.
Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 52 week study period.
Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
Participation as a subject in any clinical study within the 12 weeks prior to Day 1.
Any systemic with an investigational agent in the past 3 months prior to Day 1.
The use of long acting intraocular steroids or photodynamic therapy in the 6 months prior to day 1.
Any history of allergy to povidone iodine.
Pregnant or breast-feeding women
Women of childbearing potential* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
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| Name | Affiliation | Role |
|---|---|---|
| Rishi P Singh, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cole Eye Institute, Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26445522 | Result | Singh RP, Srivastava SK, Ehlers JP, Silva FQ, Bedi R, Schachat AP, Kaiser PK. A single-arm, investigator-initiated study of the efficacy, safety, and tolerability of intravitreal aflibercept injection in subjects with exudative age-related macular degeneration previously treated with ranibizumab or bevacizumab (ASSESS study): 12-month analysis. Clin Ophthalmol. 2015 Sep 22;9:1759-66. doi: 10.2147/OPTH.S87043. eCollection 2015. | |
| 24836866 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Group | Subjects were included in the study if they met the following criteria: (1) active subfoveal choroidal neovascularization secondary to exudative Age-related Macular Degeneration (AMD) confirmed by fluorescein angiography (2) E-ETDRS vision of 25 to 80 letters (Snellen equivalent of ~20/25 to 20/320) (3) at least one prior injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab (Avastin and Lucentis, respectively; Genentech Inc, South San Francisco, California, USA) within 3 months of enrollment, and (4) had an initial response on optical coherence tomography (OCT) defined as a decrease of retinal edema and/or subretinal fluid to anti-Vascular Endothelial Growth Factor (anti-VEGF) injections followed by recurrent increase in fluid on OCT (further defined as intraretinal, cystoid, subretinal fluid, or worsening pigment epithelial detachment) or the presence of a new hemorrhage on clinical examination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
26 eyes, 01 eye per subject
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Group | Subjects were included in the study if they met the following criteria: (1) active subfoveal choroidal neovascularization secondary to exudative AMD confirmed by fluorescein angiography (2) E-ETDRS vision of 25 to 80 letters (Snellen equivalent of ~20/25 to 20/320) (3) at least one prior injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab (Avastin and Lucentis, respectively; Genentech Inc, South San Francisco, CA, USA) within 3 months of enrollment, and (4) had an initial response on optical coherence tomography (OCT) defined as a decrease of retinal edema and/or subretinal fluid to anti-VEGF injections followed by recurrent increase in fluid on OCT (further defined as intraretinal, cystoid, subretinal fluid, or worsening pigment epithelial detachment) or the presence of a new hemorrhage on clinical examination. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Central Subfield Thickness From Baseline at 12 Months | The mean absolute change from baseline central subfield thickness at 12 months as measured by SDOCT | Posted | Mean | Standard Deviation | µm | baseline and 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Group | Subjects were included in the study if they met the following criteria: (1) active subfoveal choroidal neovascularization secondary to exudative AMD confirmed by fluorescein angiography (2) E-ETDRS vision of 25 to 80 letters (Snellen equivalent of ~20/25 to 20/320) (3) at least one prior injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab (Avastin and Lucentis, respectively; Genentech Inc, South San Francisco, CA, USA) within 3 months of enrollment, and (4) had an initial response on optical coherence tomography (OCT) defined as a decrease of retinal edema and/or subretinal fluid to anti-VEGF injections followed by recurrent increase in fluid on OCT (further defined as intraretinal, cystoid, subretinal fluid, or worsening pigment epithelial detachment) or the presence of a new hemorrhage on clinical examination. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract progression | Eye disorders | Patient began noticing a myopic shift, and the vision loss due to cataract progression was identified. The patient underwent uncomplicated phacoemulsification and lens implant placement with significant improvement in visual acuity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract progression | Eye disorders |
The drawbacks of this study included the small sample size and only 12 months of follow up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rishi Singh | Cleveland Clinic Foundation | 330-888-4000 | singhr@ccf.org |
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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Baseline and 12 months |
| Change in Macular Volume From Baseline at 12 Months. | Mean absolute change from baseline in macular volume at 12 months. | baseline and 12 months |
| Change in Cube Average Thickness From Baseline at 12 Months | Mean absolute change in cube average thickness as measured by SDOCT from baseline at 12 months. | baseline and 12 months |
| Percentage of Patients Who Gained Greater Than 15 Letters of Vision From Baseline at 12 Months. | The percentage of patients who gained greater than 15 letters of vision from baseline to 12 months. | baseline and 12 months |
| Percentage of Patients Who Lost Greater Than 15 Letters of Vision From Baseline at 12 Months | The percentage of patients who lost greater than 15 letters of vision from baseline at 12 months. | baseline and 12 months |
| Percentage of Subjects Who Were 20/40 or Better at Month 12. | Percentage of subjects who had vision acuity of 20/40 or better at month 12. | month 12 |
| Percentage of Subjects Who Were 20/200 or Worse at Month 12. | Percentage of subjects who had visual acuity of 20/200 or worse at month 12. | month 12 |
| Result |
| Singh RP, Srivastava S, Ehlers JP, Bedi R, Schachat AP, Kaiser PK. A single-arm, investigator-initiated study of the efficacy, safety and tolerability of intravitreal aflibercept injection in subjects with exudative age-related macular degeneration, previously treated with ranibizumab or bevacizumab: 6-month interim analysis. Br J Ophthalmol. 2014 Jun;98 Suppl 1(Suppl 1):i22-27. doi: 10.1136/bjophthalmol-2013-304798. |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Length of time since diagnosis of exudative AMD | Mean | Standard Deviation | months |
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| Time since last injection prior to study enrollment | Mean | Standard Deviation | days |
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| Previous treatment | Count of Participants | Participants |
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| Average number of treatments prior to study entry | Mean | Standard Deviation | injections |
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| Average number of injections during study | Mean | Standard Deviation | injections |
|
| E-ETDRS best-corrected visual acuity (BCVA) letter score | The scale provided is the Eletronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) best corrected visual acuity scale. This is a very common ophthalmology measurement tool and it is quite clear from its name. Values that are higher are considered better and values that are lower are considered worse. Minimum E-ETDRS was 24 E-ETDRS letters and maximum E-ETDRS was 80 E-ETDRS letters. | Mean | Standard Deviation | E-ETDRS letters |
|
| Best Corrected Visual Acuity Snellen equivalent | The Snellen Equivalent is a numerical values from 90-0 with the higher value indicated better visual acuity | Mean | Full Range | E-ETDRS letters |
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| Central subfield thickness | Mean | Standard Deviation | µm |
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| Secondary | Change in Best-corrected Visual Acuity From Baseline at 12 Months | The mean absolute change from baseline in best-corrected visual acuity score at 12 months as measured by Eletronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) protocol. There were no sub scales used. These are common methods for ophthalmology studies to report their findings. The scale provided is the Electronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) best corrected visual acuity scale. Values that are higher are considered better and values that are lower are considered worse. Minimum E-ETDRS was 24 E-ETDRS letters and maximum E-ETDRS was 80 E-ETDRS letters. | Posted | Mean | Standard Deviation | E-ETDRS letters | Baseline and 12 months |
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| Secondary | Change in Macular Volume From Baseline at 12 Months. | Mean absolute change from baseline in macular volume at 12 months. | Posted | Mean | Standard Deviation | mm3 | baseline and 12 months |
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| Secondary | Change in Cube Average Thickness From Baseline at 12 Months | Mean absolute change in cube average thickness as measured by SDOCT from baseline at 12 months. | Posted | Mean | Standard Deviation | µm | baseline and 12 months |
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| Secondary | Percentage of Patients Who Gained Greater Than 15 Letters of Vision From Baseline at 12 Months. | The percentage of patients who gained greater than 15 letters of vision from baseline to 12 months. | Posted | Count of Participants | Participants | baseline and 12 months |
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| Secondary | Percentage of Patients Who Lost Greater Than 15 Letters of Vision From Baseline at 12 Months | The percentage of patients who lost greater than 15 letters of vision from baseline at 12 months. | Posted | Count of Participants | Participants | baseline and 12 months |
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| Secondary | Percentage of Subjects Who Were 20/40 or Better at Month 12. | Percentage of subjects who had vision acuity of 20/40 or better at month 12. | Posted | Count of Participants | Participants | month 12 |
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| Secondary | Percentage of Subjects Who Were 20/200 or Worse at Month 12. | Percentage of subjects who had visual acuity of 20/200 or worse at month 12. | Posted | Count of Participants | Participants | month 12 |
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