Glaucoma, NeovascularPhase 3NCT02914626
Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study
A Phase 3 study testing Intravitreal ranibizumab in people with Glaucoma, Neovascular and Ranibizumab, run by LEANDRO CABRAL ZACHARIAS.
Trial summary
Neovascular glaucoma is a potentially blinding condition characterized by the growth of newvessels at the anterior part of the eye. This growth is driven by the overexpression of a protein called Vascular Endothelial Growth Factor (VEGF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Neovascular, Ranibizumab
- What is being tested?
- Intravitreal ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2018
- Phase
- Phase 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
- IOP greater than 24 mmHg
- Iris or anterior chamber neovascularization
- At least 120 degrees of opened anterior chamber angle
Who cannot join
- Visual acuity worse than counting fingers in the fellow eye
- No light perception in the treated eye
- Any ocular infectious disease
- Use of systemic steroids
- Lack of media transparency precluding laser photocoagulation
- Thromboembolic disease
Show all 9Show fewer
- Known hypersensitivity to ranibizumab
- Female participants at childbearing age not using oral contraceptives
- Use of intravitreal anti-VEGF over the last 30 days.
Trial locations and contacts
No sites are listed yet.
About this study
Neovascular glaucoma is a potentially blinding condition characterized by the growth of newvessels at the anterior part of the eye. This growth is driven by the overexpression of a protein called Vascular Endothelial Growth Factor (VEGF). That happens in diseases such as diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular pressure (IOP). Traditional treatment include laser photocoagulation of the retina in order to decrease VEGF formation. The investigators postulate that the use of anti-VEGF intravitreal injections may accelerate recovery and decrease the need of surgery in cases of neovascular glaucoma.
Read the detailed description
This is a prospective, randomized controlled study that aims to evaluate the efficacy of ranibizumab (Lucentis®) as an adjunct in the treatment of patients with neovascular glaucoma.
28 patients with neovascular glaucoma (14 in the study group and 14 in the control standard of care group) will be recruited at a single center- University of Sao Paulo Medical School General Hospital. A complete ophthalmologic exam will be carried out, including the obtention of an informed consent for eligible patients willing to participate on the study.
Patients will be randomly assigned to either standard of care- retinal laser photocoagulation and clinical management of intraocular pressure with drops, or standard of care plus intravitreal ranibizumab injections. Two injections will be performed 30 days apart. The patients will be followed for 6 months.
- Conditions
- Glaucoma, Neovascular, Ranibizumab
- Being tested
- Intravitreal ranibizumab
- Keywords
- Glaucoma, Neovascular, Ranibizumab, Intraocular pressure, anti-VEGF, intravitreal injection
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal ranibizumabDrug
Also called Lucentis
Intravitreal ranibizumab injection
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Standard of care therapy plus intravitreal ranibizumab injections Receives: Drug: Intravitreal ranibizumab |
| Control | Sham comparator | Standard of care therapy Receives: Drug: Intravitreal ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured: 6 months
Secondary outcomes (4)
Anterior segment neovascularization
Measured: 6 months
Best corrected visual acuity
Measured: 6 months
Number of drugs needed for IOP control
Measured: 6 months
Need for IOP control surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, NeovascularStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LEANDRO CABRAL ZACHARIAS
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, LEANDRO CABRAL ZACHARIAS, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914626
- Sponsor's protocol ID
- USaoPauloGH 294.326
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rittiphairoj T, Roberti G, Michelessi M. Anti-vascular endothelial growth factor for neovascular glaucoma. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD007920. doi: 10.1002/14651858.CD007920.pub4.
PubMed 37010901
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02914626
- Acronym / sponsor ID
- USaoPauloGH 294.326
- Conditions
- Glaucoma, Neovascular, Ranibizumab
- Keywords
- Glaucoma, Neovascular, Ranibizumab, Intraocular pressure, anti-VEGF, intravitreal injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- LEANDRO CABRAL ZACHARIASUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 26 Sep 2016 (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.
Neovascular glaucoma is a potentially blinding condition characterized by the growth of newvessels at the anterior part of the eye. This growth is driven by the overexpression of a protein called Vascular Endothelial Growth Factor (VEGF). That happens in diseases such as diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular pressure (IOP). Traditional treatment include laser photocoagulation of the retina in order to decrease VEGF formation. The investigators postulate that the use of anti-VEGF intravitreal injections may accelerate recovery and decrease the need of surgery in cases of neovascular glaucoma.
Detailed description
This is a prospective, randomized controlled study that aims to evaluate the efficacy of ranibizumab (Lucentis®) as an adjunct in the treatment of patients with neovascular glaucoma.
28 patients with neovascular glaucoma (14 in the study group and 14 in the control standard of care group) will be recruited at a single center- University of Sao Paulo Medical School General Hospital. A complete ophthalmologic exam will be carried out, including the obtention of an informed consent for eligible patients willing to participate on the study.
Patients will be randomly assigned to either standard of care- retinal laser photocoagulation and clinical management of intraocular pressure with drops, or standard of care plus intravitreal ranibizumab injections. Two injections will be performed 30 days apart. The patients will be followed for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: Intravitreal ranibizumabStandard of care therapy plus intravitreal ranibizumab injections |
| Control | Sham comparator | Drug: Intravitreal ranibizumabStandard of care therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IOP greater than 24 mmHg
- Iris or anterior chamber neovascularization
- At least 120 degrees of opened anterior chamber angle
Key exclusion criteria (9 listed)
- Visual acuity worse than counting fingers in the fellow eye
- No light perception in the treated eye
- Any ocular infectious disease
- Use of systemic steroids
- Lack of media transparency precluding laser photocoagulation
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 ranibizumabAlso: LucentisIntravitreal ranibizumab injection | Drug | Control, Ranibizumab |
Primary outcome
Intraocular pressure
Time frame: 6 months
4 secondary outcomes
Anterior segment neovascularization
Time frame: 6 months
Best corrected visual acuity
Time frame: 6 months
Number of drugs needed for IOP control
Time frame: 6 months
Need for IOP control surgery
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Derived from this study: PubMed 37010901Rittiphairoj T, Roberti G, Michelessi M. Anti-vascular endothelial growth factor for neovascular glaucoma. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD007920. doi: 10.1002/14651858.CD007920.pub4.
Related trials for Glaucoma, Neovascular
RecruitingObservational study
Observation of Iris Blood Flow Via OCTA in Diabetic Neovascular Glaucoma
Neovascular Glaucoma, Type 2 Diabetes
RecruitingObservational study
Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)
Neovascular Glaucoma
Active, not recruiting
Minimally Invasive Suprachoroidal Drainage for the Treatment of Neovascular Glaucoma
Neovascular Glaucoma
Recruiting
Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT
Glaucoma, Neovascular, Vascular Endothelial Growth Factor Overexpression
Active, not recruitingPhase 1
KDR2-2 Suspension Eyedrop in the Treatment of Neovascular Glaucoma (KDR-NVG) Trial
Neovascular Glaucoma, Neovascularization
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravitreal ranibizumab in people with Glaucoma, Neovascular and Ranibizumab, run by LEANDRO CABRAL ZACHARIAS.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leandro C Zacharias, MD, PhD (5511-2661-7871, lczacharias@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: 6 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 NCT02914626, which also lists 1 linked publication.
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 27 Sep 2016.