Central Retinal Vein OcclusionPhase 1/2ANDROIDNCT01724554
Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion
A Phase 1/2 study testing Intravitreal Aflibercept Injection in people with Central Retinal Vein Occlusion and Proliferative Diabetic Retinopathy, run by Ophthalmic Consultants of Boston at 1 site in United States.
Trial summary
The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or Proliferative Diabetic Retinopathy (PDR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion, Proliferative Diabetic Retinopathy
- What is being tested?
- Intravitreal Aflibercept Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Oct 2014
- Phase
- Phase 1/2
- 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
- Diagnosis of one or more of the following:
- Proliferative retinopathy (PDR) Macular edema secondary to CRVO Proliferative disease secondary to CRVO (anterior segment or posterior segment neovascularization).
- Be in need of IAI treatment, whether previously treated or treatment-naïve.
- Age > 18 years.
Who cannot join
- Subjects with macular edema secondary to diabetic retinopathy without concomitant proliferative diabetic retinopathy.
- Subjects with cataract or other media opacities impairing adequate visualization of the retina to the extent that good quality images are impossible.
- Presence of any substantial ocular disease (other than diabetic retinopathy or central retinal vein occlusion) 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, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
- Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication).
- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
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- Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study.
- Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline.
- History of vitrectomy surgery in the study eye.
- Subjects with 12 or more anti-VEGF injections within 24 months prior to Screening.
- Subjects who received anti-VEGF therapy within 30 days of Screening or received steroid or laser therapy within 90 days of Screening.
- Subjects allergic to fluorescein, povidone iodine (Betadyne) or aflibercept
- Pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
About this study
Official title: A Single-center, Open-label Study Evaluating the Impact of Repeat Intravitreal Injections of Aflibercept on Capillary Non-Perfusion (CNP) in Subjects With Proliferative Retinopathy and/or Macular Edema Secondary to Proliferative Diabetic Retinopathy and Central Retinal Venous Occlusive Disease
The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or Proliferative Diabetic Retinopathy (PDR).
Read the detailed description
Protocol available upon request.
- Being tested
- Intravitreal Aflibercept Injection
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Aflibercept InjectionDrug
Also called IAI
Aflibercept administered to the eye intravitreally either every month or every other month.
| Study group | Role | What they receive |
|---|---|---|
| Every Month Treatment | Experimental | Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study. Receives: Drug: Intravitreal Aflibercept Injection |
| Every Month, then Every Other Month | Experimental | Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the first 6 months, then every other month for the next 6 months. Retreatment criteria will allow for patients to be treated every month in the second 6 months if needed. Receives: Drug: Intravitreal Aflibercept Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Capillary Non-Perfusion
To determine mean change in the presence and amount of capillary non-perfusion as measured by wide-angle angiography using Optos 200Tx system at Baseline, Month 3, Month 6, and Month 12.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Retinal Vein OcclusionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants of Boston
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Heier, MD, Principal investigator, Ophthalmic Consultants of Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724554
- Sponsor's protocol ID
- ANDROID
- Acronym
- ANDROID
- Status last verified
- May 2015
- First submitted
- 7 Nov 2012
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label Study Evaluating the Impact of Repeat Intravitreal Injections of Aflibercept on Capillary Non-Perfusion (CNP) in Subjects With Proliferative Retinopathy and/or Macular Edema Secondary to Proliferative Diabetic Retinopathy and Central Retinal Venous Occlusive Disease
- ClinicalTrials.gov ID
- NCT01724554
- Acronym / sponsor ID
- ANDROID / ANDROID
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ophthalmic Consultants of BostonUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Nov 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Nov 2012 (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.
The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or Proliferative Diabetic Retinopathy (PDR).
Detailed description
Protocol available upon request.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Every Month Treatment | Experimental | Drug: Intravitreal Aflibercept InjectionPatients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study. |
| Every Month, then Every Other Month | Experimental | Drug: Intravitreal Aflibercept InjectionPatients will receive Intravitreal Aflibercept Injection (IAI) every month for the first 6 months, then every other month for the next 6 months. Retreatment criteria will allow for patients to be treated every month in the second 6 months if needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of one or more of the following:
- Proliferative retinopathy (PDR) Macular edema secondary to CRVO Proliferative disease secondary to CRVO (anterior segment or posterior segment neovascularization).
- Be in need of IAI treatment, whether previously treated or treatment-naïve.
- Age > 18 years.
Key exclusion criteria (13 listed)
- Subjects with macular edema secondary to diabetic retinopathy without concomitant proliferative diabetic retinopathy.
- Subjects with cataract or other media opacities impairing adequate visualization of the retina to the extent that good quality images are impossible.
- Presence of any substantial ocular disease (other than diabetic retinopathy or central retinal vein occlusion) 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, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
- Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication).
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 InjectionAlso: IAIAflibercept administered to the eye intravitreally either every month or every other month. | Drug | Every Month Treatment, Every Month, then Every Other Month |
Primary outcome
Mean Change in Capillary Non-Perfusion
Time frame: 12 months
To determine mean change in the presence and amount of capillary non-perfusion as measured by wide-angle angiography using Optos 200Tx system at Baseline, Month 3, Month 6, and Month 12.
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 22 May 2015.
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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.
Jeffrey S Heier, MD principal investigator
Ophthalmic Consultants of Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravitreal Aflibercept Injection in people with Central Retinal Vein Occlusion and Proliferative Diabetic Retinopathy, run by Ophthalmic Consultants of Boston 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 4 inclusion and 13 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 22 May 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean Change in Capillary Non-Perfusion (time frame: 12 months). 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 22 May 2015.