Neovascular GlaucomaNCT01711879
Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
A study testing Aflibercept in people with Neovascular Glaucoma, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This 52 week study will assess the use of intravitreal aflibercept injections in patients with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Neovascular Glaucoma
- 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
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Oct 2015
- Phase
- Interventional
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of neovascular glaucoma (Stage I-II)
- Individuals who are ages 21-90 years old; male or female of any race
- Presence of neovascularization of the iris and/or angle
- At least 90 degrees of "unzipped" anterior chamber angle as noted by gonioscopy. (a "zipped angle is the term used for a drainage angle that is slowly closing due to scar tissue from the neovascularization process)
- Visual acuity of light perception or better in the study eye
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Who cannot join
- Use of intravitreal anti-VEGF agents in the study eye in the past 3 months.
- Full PRP in the study eye
- Prior vitrectomy in the study eye
- Prior trabeculectomy or other filtration surgery in the study eye
- Active ocular or periocular infection in the study eye
- Ocular conditions (Cataract or vitreous hemorrhage) that might require surgery in next 12 months
Show all 12Show fewer
- Allergy to fluorescein dye
- Any past use of systemic anti-VEGF medication
- Myocardial infarction within 6 months prior to study enrollment
- Stroke within 6 months prior to study enrollment
- Pregnant or breast-feeding women
- Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Lions Eye Institute
Aurora, Colorado, 80045
About this study
This 52 week study will assess the use of intravitreal aflibercept injections in patients with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.
The investigators hypothesize that the neovascularization of the iris and angle present in neovascular glaucoma will resolve more quickly in eye treated with intravitreal aflibercept injection alone and result in increased comfort and preservation of visual field as compared to current standard of care utilizing pan-retinal photocoagulation. The advantages to intravitreal aflibercept injection use could include resolution of NVI/NVA (neovascularization of the iris/neovascularization of the angle) leading to quicker pain relief and quicker lowering of IOP (intraocular pressure).
Read the detailed description
The two arms of this study will compare current common practice (initial intravitreal anti-VEGF (vascular endothelial growth factor) to study treatment (VEGF) injection only) for 52 weeks.
This single center study will consist of 20 patients with NVG. Patients will be randomized to:
- Group A: A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks. or
- Group B: 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Clinical assessment will include pain assessment (Universal Pain Scale), best corrected visual acuity (ETDRS), ophthalmic examination, anterior segment assessment including number of clock-hours of NVI/NVA, gonioscopy, anterior segment photography, visual field test (Humphrey SITA- Standard 24-2), optic nerve OCT (Zeiss Cirrus Optic Disc Cube 200x200), macular OCT (Cube scan 512 x 128 and 5 Line Raster), fluorescein angiography (initial iris phase followed by standard retinal angiography), and concurrent medical/ocular medications. Qualitative assessment of neovascularization will be made by the investigator based on comparison to baseline angiography.
- Conditions
- Neovascular Glaucoma
- Being tested
- Aflibercept
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Also called Eylea
Details covered in arm description
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept with Laser | Active comparator | A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks Receives: Drug: Aflibercept |
| Aflibercept | Experimental | 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks. Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events
Measured: 2 year
Severity of Adverse Events
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events
Measured: 2 year
Secondary outcomes (13)
Rate and Extent of Resolution of Neovascularization
Compare between Groups A and B the Rate and extent of resolution of neovascularization in patients with NVG Stages 1 \& 2.
Measured: 1 year
Intraocular Pressure (mmHg) at Baseline
Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Measured: Baseline
Intraocular Pressure (mmHg) at Week 52
Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Measured: Week 52
Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B
Comparison between patients, groups A and B, that lost > 5 letters on visual acuity
Measured: Baseline to Week 52
Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity
Comparison of patients in each, group A and group B, that gained > 5 letters on visual acuity
Measured: Baseline to Week 52
Visual Acuity at Baseline
Comparison of visual acuity between groups A and B
Measured: Baseline
Visual Acuity at Week 52
Comparison of visual acuity at Week 52 between groups A and B
Measured: Week 52
Comparison of the Visual Field Between Groups
Comparison of the Visual field s measured by HVF 24-2 SITA Standards between groups A and B
Measured: 1 year
Measure of the Optical Coherence Tomography(OCT) Outcomes
Evaluation of the Optical Coherence Tomography(OCT) outcomes (average retinal nerve fiber layer(RNFL) and central macular thickness), Compared between groups A and B.
Measured: Baseline to Week 52
Number of Patients With Need for Surgical Intervention
Comparison between groups A and B and the need for surgical intervention in both arms during the follow-up period
Measured: 1 year
Number of Participants With Need for Additional IOP Lowering Medications
Comparison between groups A and B for the need of additional IOP lowering medications
Measured: 1 year
Extent of Resolution of Neovascularization Between Groups
Comparison of groups A and B and the extent of resolution of neovascularization in patients with NVG Stages 1 \& 2
Measured: 1 year
Evaluation of the Average Retinal Nerve Fiber Layer (RNFL)
Comparison between groups A and B of the average retinal nerve fiber layer (RNFL) as measured by Optical Coherence Tomography (OCT)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2015
- Study completionOct 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.
- Other trials for Neovascular GlaucomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malik Y Kahook, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711879
- Sponsor's protocol ID
- 12-1526
- Status last verified
- Feb 2022
- First submitted
- 18 Oct 2012
- Last updated
- 18 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
- ClinicalTrials.gov ID
- NCT01711879
- Acronym / sponsor ID
- 12-1526
- Conditions
- Neovascular Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 52 week study will assess the use of intravitreal aflibercept injections in patients with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.
The investigators hypothesize that the neovascularization of the iris and angle present in neovascular glaucoma will resolve more quickly in eye treated with intravitreal aflibercept injection alone and result in increased comfort and preservation of visual field as compared to current standard of care utilizing pan-retinal photocoagulation. The advantages to intravitreal aflibercept injection use could include resolution of NVI/NVA (neovascularization of the iris/neovascularization of the angle) leading to quicker pain relief and quicker lowering of IOP (intraocular pressure).
Detailed description
The two arms of this study will compare current common practice (initial intravitreal anti-VEGF (vascular endothelial growth factor) to study treatment (VEGF) injection only) for 52 weeks.
This single center study will consist of 20 patients with NVG. Patients will be randomized to:
- Group A: A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks. or
- Group B: 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Clinical assessment will include pain assessment (Universal Pain Scale), best corrected visual acuity (ETDRS), ophthalmic examination, anterior segment assessment including number of clock-hours of NVI/NVA, gonioscopy, anterior segment photography, visual field test (Humphrey SITA- Standard 24-2), optic nerve OCT (Zeiss Cirrus Optic Disc Cube 200x200), macular OCT (Cube scan 512 x 128 and 5 Line Raster), fluorescein angiography (initial iris phase followed by standard retinal angiography), and concurrent medical/ocular medications. Qualitative assessment of neovascularization will be made by the investigator based on comparison to baseline angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aflibercept with Laser | Active comparator | Drug: AfliberceptA single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks |
| Aflibercept | Experimental | Drug: Aflibercept2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with a diagnosis of neovascular glaucoma (Stage I-II)
- Individuals who are ages 21-90 years old; male or female of any race
- Presence of neovascularization of the iris and/or angle
- At least 90 degrees of "unzipped" anterior chamber angle as noted by gonioscopy. (a "zipped angle is the term used for a drainage angle that is slowly closing due to scar tissue from the neovascularization process)
- Visual acuity of light perception or better in the study eye
Key exclusion criteria (12 listed)
- Use of intravitreal anti-VEGF agents in the study eye in the past 3 months.
- Full PRP in the study eye
- Prior vitrectomy in the study eye
- Prior trabeculectomy or other filtration surgery in the study eye
- Active ocular or periocular infection 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 |
|---|---|---|
| AfliberceptAlso: EyleaDetails covered in arm description | Drug | Aflibercept, Aflibercept with Laser |
Primary outcome
Incidence of Adverse Events
Time frame: 2 year
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events
Severity of Adverse Events
Time frame: 2 year
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events
13 secondary outcomes
Rate and Extent of Resolution of Neovascularization
Time frame: 1 year
Intraocular Pressure (mmHg) at Baseline
Time frame: Baseline
Intraocular Pressure (mmHg) at Week 52
Time frame: Week 52
Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B
Time frame: Baseline to Week 52
Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity
Time frame: Baseline to Week 52
Visual Acuity at Baseline
Time frame: Baseline
Visual Acuity at Week 52
Time frame: Week 52
Comparison of the Visual Field Between Groups
Time frame: 1 year
Measure of the Optical Coherence Tomography(OCT) Outcomes
Time frame: Baseline to Week 52
Number of Patients With Need for Surgical Intervention
Time frame: 1 year
Number of Participants With Need for Additional IOP Lowering Medications
Time frame: 1 year
Extent of Resolution of Neovascularization Between Groups
Time frame: 1 year
Evaluation of the Average Retinal Nerve Fiber Layer (RNFL)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Malik Y Kahook, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aflibercept in people with Neovascular Glaucoma, run by University of Colorado, Denver 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 7 inclusion and 12 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 18 Mar 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2021). 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?
Incidence of Adverse Events (time frame: 2 year). The study lists 2 primary outcomes in all. 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 18 Mar 2022.