Exudative Macular DegenerationPhase 4NCT01617148
Wet Macular Degeneration Study to Compare Ranibizumab or Bevacizumab to Aflibercept
A Phase 4 study testing Aflibercept in people with Exudative Macular Degeneration, run by Rishi Singh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Exudative Macular Degeneration
- What is being tested?
- Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- Presence of fluid by either optical coherence tomography (OCT) or clinical examination (further defined as intraretinal, cystoid, subretinal, worsening pigment epithelial detachment)
- Presence of new hemorrhage on clinical examination
Who cannot join
- 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.
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- 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)
- *Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: 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)
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.
Read the detailed description
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.
- Conditions
- Exudative Macular Degeneration
- Being tested
- Aflibercept
- Keywords
- Exudative Macular Degeneration, Aflibercept
- Medical subject headings
- Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 12 months
Secondary outcomes (7)
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.
Measured: Baseline and 12 months
Change in Macular Volume From Baseline at 12 Months.
Mean absolute change from baseline in macular volume at 12 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exudative Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rishi Singh
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor-investigator, Rishi Singh, The Cleveland Clinic
- Investigators
- Rishi P Singh, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617148
- Sponsor's protocol ID
- VGFTe-AMD-1211
- Status last verified
- Jul 2018
- First submitted
- 8 Jun 2012
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26445522Singh 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.
PubMed 24836866
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01617148
- Acronym / sponsor ID
- VGFTe-AMD-1211
- Conditions
- Exudative Macular Degeneration
- Keywords
- Exudative Macular Degeneration, Aflibercept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rishi SinghUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Posted 26 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Aflibercept | Experimental | Drug: AfliberceptSubjects 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfliberceptPatients 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. | Drug | Treatment with Aflibercept |
Primary outcome
Change in Central Subfield Thickness From Baseline at 12 Months
Time frame: baseline and 12 months
The mean absolute change from baseline central subfield thickness at 12 months as measured by SDOCT
7 secondary outcomes
Change in Best-corrected Visual Acuity From Baseline at 12 Months
Time frame: Baseline and 12 months
Change in Macular Volume From Baseline at 12 Months.
Time frame: baseline and 12 months
Change in Cube Average Thickness From Baseline at 12 Months
Time frame: baseline and 12 months
Percentage of Patients Who Gained Greater Than 15 Letters of Vision From Baseline at 12 Months.
Time frame: baseline and 12 months
Percentage of Patients Who Lost Greater Than 15 Letters of Vision From Baseline at 12 Months
Time frame: baseline and 12 months
Percentage of Subjects Who Were 20/40 or Better at Month 12.
Time frame: month 12
Percentage of Subjects Who Were 20/200 or Worse at Month 12.
Time frame: month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26445522Singh 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.
- Results publication: PubMed 24836866Singh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rishi P Singh, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept in people with Exudative Macular Degeneration, run by Rishi Singh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Central Subfield Thickness From Baseline at 12 Months (time frame: baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01617148, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.