Proliferative Diabetic RetinopathyPhase 2/3ACTNCT01813773
Treatment With Intravitreal Aflibercept Injection For Proliferative Diabetic Retinopathy, The A.C.T Study
A Phase 2/3 study testing Intravitreal Aflibercept Injection (IAI) in people with Proliferative Diabetic Retinopathy, run by Ophthalmic Consultants of Long Island at 1 site in United States.
Trial summary
To assess the safety of intravitreal aflibercept injection in the treatment of proliferative diabetic retinopathy (PDR) by evaluating the incidence and severity of adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Intravitreal Aflibercept Injection (IAI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Apr 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be enrolled if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age 18 years and older
- Retinal neovascularization secondary to diabetic retinopathy
- Best corrected visual acuity in the study eye better than 20/320 using an ETDRS chart
- In the event that either eye of a potential subject meets enrollment criteria, the worse sighted eye will be enrolled into the study. Only one eye can be enrolled in the study.
Who cannot join
- Pregnant or breast-feeding women Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study and for at least 30 days after the last administration of study drug for women and at least 90 days after the last administration for men (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];; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
- Contraception is not required for men with documented vasectomy.
- Pregnancy testing and contraception are not required for women with documented hysterectomy.
- HbA1C >10 within approximately 90 days of Screening visit
- Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
- Prior treatment with systemic anti-VEGF agents
Show all 24Show fewer
- Presence of any substantial ocular disease (other than diabetic retinopathy) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
- Prior treatment with anti-VEGF therapy in the study eye within 90 days of baseline
- Prior treatment with PRP within 60 days
- Prior treatment with IAI.
- Prior treatment with triamcinolone in the study eye within 180 days of baseline.
- Prior treatment with dexamethasone in the study eye within 30 days prior to baseline.
- Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline
- History of vitrectomy surgery in the study eye.
- Active intraocular inflammation (grade trace or above) in the study eye
- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Uncontrolled glaucoma in the study eye (defined as IOP ≥ 25 mmHg despite treatment with anti-glaucoma medication)
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 180 days of study enrollment.
- History of allergy to fluorescein, topical antibiotic, povidone iodine (Betadine) or aflibercept.
- Presence of vitreous hemorrhage that completely obstructs the view of the optic nerve (amount of vitreous hemorrhage will also be gated by 20/320 criteria)
- Presence of TRD in the study eye.
- Presence of pre-retinal fibrosis (not including epiretinal membrane)
- Unwilling to discontinue sperm bank donation for any period of time after IAI treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
About this study
To assess the safety of intravitreal aflibercept injection in the treatment of proliferative diabetic retinopathy (PDR) by evaluating the incidence and severity of adverse events.
Read the detailed description
- Single center, open label pilot study using 2.0mg intravitreal aflibercept injection. (IAI)
- 20 subjects with active PDR to be randomized into 2 groups, i.e. groups A and B.
- Subjects in both arms will be followed-up every 4 weeks until week 52.
- The primary endpoint of the study will be at week 52.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Intravitreal Aflibercept Injection (IAI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Aflibercept Injection (IAI)Drug
Also called Eylea
EYLEA (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells.
| Study group | Role | What they receive |
|---|---|---|
| Group A - IAI every 4 weeks | Experimental | Receives 5 injections of Intravitreal Aflibercept Injection (IAI) beginning Day 1, and then at weeks 4, 8, 12, and 16. Following the 5 initial injections, this group will continue to receive IAI every 4 weeks, beginning week 20, through week 48. Receives: Drug: Intravitreal Aflibercept Injection (IAI) |
| Group B - IAI every 8 weeks | Experimental | Receives 5 injections of Intravitreal Aflibercept Injection (IAI) beginning Day 1, and then at weeks 4, 8, 12, and 16. Following the 5 initial injections, this group will receive IAI every 8 weeks, beginning week 24, through week 48. Receives: Drug: Intravitreal Aflibercept Injection (IAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events of intravitreal aflibercept injection in the treatment of PDR.
Measured: The primary endpoint of the study will be at week 52.
Secondary outcomes (9)
Mean change in the area of fluorescein leakage in mm2 (area of neovascularization) compared to baseline.
Measured: At Weeks 24 and 52
Proportion of subjects with complete regression of neovascularization
Measured: At Weeks 24 and 52
Mean change in ETDRS BCVA from baseline
Measured: At Weeks 24 and 52
Proportion of subjects gaining > 5 letters, > 10 letters and > 15 letters from baseline
Measured: At Weeks 24 and 52
Proportion of subjects losing > 5 letters from baseline
Measured: At Weeks 24 and 52
Mean change in retinal thickness from baseline as demonstrated by Spectral Domain OCT Imaging
Measured: At Weeks 24 and 52
Proportion of subjects without vitreous hemorrhage or pre-retinal hemorrhage
Measured: At Weeks 24 and 52
Proportion of subjects with complete avoidance of panretinal laser photocoagulation (PRP)/ additional PRP
Measured: At Weeks 24 and 52
Proportion of subjects with avoidance of vitrectomy
Measured: At Weeks 24 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants of Long Island
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Glenn L Stoller, MD, Principal investigator, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813773
- Sponsor's protocol ID
- THE A.C.T. STUDY
- Acronym
- ACT
- Status last verified
- Jun 2016
- First submitted
- 25 Feb 2013
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Intravitreal Aflibercept Injection For Proliferative Diabetic Retinopathy, The A.C.T Study
- ClinicalTrials.gov ID
- NCT01813773
- Acronym / sponsor ID
- ACT / THE A.C.T. STUDY
- Conditions
- Proliferative Diabetic Retinopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ophthalmic Consultants of Long IslandUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Mar 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety of intravitreal aflibercept injection in the treatment of proliferative diabetic retinopathy (PDR) by evaluating the incidence and severity of adverse events.
Detailed description
- Single center, open label pilot study using 2.0mg intravitreal aflibercept injection. (IAI)
- 20 subjects with active PDR to be randomized into 2 groups, i.e. groups A and B.
- Subjects in both arms will be followed-up every 4 weeks until week 52.
- The primary endpoint of the study will be at week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - IAI every 4 weeks | Experimental | Drug: Intravitreal Aflibercept Injection (IAI)Receives 5 injections of Intravitreal Aflibercept Injection (IAI) beginning Day 1, and then at weeks 4, 8, 12, and 16. Following the 5 initial injections, this group will continue to receive IAI every 4 weeks, beginning week 20, through week 48. |
| Group B - IAI every 8 weeks | Experimental | Drug: Intravitreal Aflibercept Injection (IAI)Receives 5 injections of Intravitreal Aflibercept Injection (IAI) beginning Day 1, and then at weeks 4, 8, 12, and 16. Following the 5 initial injections, this group will receive IAI every 8 weeks, beginning week 24, through week 48. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age 18 years and older
- Retinal neovascularization secondary to diabetic retinopathy
- Best corrected visual acuity in the study eye better than 20/320 using an ETDRS chart
- In the event that either eye of a potential subject meets enrollment criteria, the worse sighted eye will be enrolled into the study. Only one eye can be enrolled in the study.
Key exclusion criteria (24 listed)
- Pregnant or breast-feeding women Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study and for at least 30 days after the last administration of study drug for women and at least 90 days after the last administration for men (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];; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
- Contraception is not required for men with documented vasectomy.
- Pregnancy testing and contraception are not required for women with documented hysterectomy.
- HbA1C >10 within approximately 90 days of Screening visit
- Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
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 |
|---|---|---|
| Intravitreal Aflibercept Injection (IAI)Also: EyleaEYLEA (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells. | Drug | Group A - IAI every 4 weeks, Group B - IAI every 8 weeks |
Primary outcome
Incidence and severity of adverse events of intravitreal aflibercept injection in the treatment of PDR.
Time frame: The primary endpoint of the study will be at week 52.
9 secondary outcomes
Mean change in the area of fluorescein leakage in mm2 (area of neovascularization) compared to baseline.
Time frame: At Weeks 24 and 52
Proportion of subjects with complete regression of neovascularization
Time frame: At Weeks 24 and 52
Mean change in ETDRS BCVA from baseline
Time frame: At Weeks 24 and 52
Proportion of subjects gaining > 5 letters, > 10 letters and > 15 letters from baseline
Time frame: At Weeks 24 and 52
Proportion of subjects losing > 5 letters from baseline
Time frame: At Weeks 24 and 52
Mean change in retinal thickness from baseline as demonstrated by Spectral Domain OCT Imaging
Time frame: At Weeks 24 and 52
Proportion of subjects without vitreous hemorrhage or pre-retinal hemorrhage
Time frame: At Weeks 24 and 52
Proportion of subjects with complete avoidance of panretinal laser photocoagulation (PRP)/ additional PRP
Time frame: At Weeks 24 and 52
Proportion of subjects with avoidance of vitrectomy
Time frame: At Weeks 24 and 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Glenn L Stoller, MD principal investigator
Ophthalmic Consultants of Long Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravitreal Aflibercept Injection (IAI) in people with Proliferative Diabetic Retinopathy, run by Ophthalmic Consultants of Long Island 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 6 inclusion and 24 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 6 Jun 2016. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of adverse events of intravitreal aflibercept injection in the treatment of PDR. (time frame: The primary endpoint of the study will be at week 52.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2016.