Proliferative Diabetic RetinopathyPhase 2ARKNCT02067013
Analysis of Aqueous and Vitreous Humor
A Phase 2 study testing Ranibizumab and No Ranibizumab in people with Proliferative Diabetic Retinopathy and Macular Degeneration, run by California Retina Consultants at 1 site in United States.
Trial summary
Clinical Retina research studies often collect aqueous samples in hopes of estimating levels of drug or cytokines in the vitreous. Little is known about how well vitreous and aqueous correlate. This study will collect vitreous and aqueous samples at the same time to evaluate and compare drug and cytokine levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Macular Degeneration, Macular Hole
- What is being tested?
- Ranibizumab and No Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2017
- Phase
- Phase 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
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Subjects with a diagnosis of tractional retinal detachment secondary to proliferative diabetic retinopathy, age-related macular degeneration with tractional or exudative retinal detachment, macular hole, epiretinal membrane, or neovascular glaucoma.
Who cannot join
- Subjects with history of vitrectomy in the study eye
- Presence of vitreous hemorrhage
- Subjects with history of laser photocoagulation in the study eye within 3 months of vitrectomy
- Subjects unwilling to undergo pars plana vitrectomy
- Subjects unwilling to receive intravitreal ranibizumab prior to pars plana vitrectomy unless diagnosis of macular hole or epiretinal membrane
- Subjects who may need or have received systemic anti-VEGF for oncology in the past year
- Subjects with history of anti-VEGF injection within 4 months before vitrectomy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California Retina Consultants - Santa Barbara Office
Santa Barbara, California, 93103
Gabriel Gordon, PhD, 805-963-1648 ext. 3034, gabe@californiaretina.com
Robert L Avery, MD
About this study
Official title: Analysis of Vitreous and Aqueous Humor for Ocular Growth Factors, Cytokines, Chemokines, and Ranibizumab Pharmacokinetics Associated With Various Retinal Disease
Clinical Retina research studies often collect aqueous samples in hopes of estimating levels of drug or cytokines in the vitreous. Little is known about how well vitreous and aqueous correlate. This study will collect vitreous and aqueous samples at the same time to evaluate and compare drug and cytokine levels.
The overall objective of this study is to evaluate the molecular concentration of growth factors, cytokines and chemokines in human aqueous humor and vitreous samples collected from individuals undergoing pars plana vitrectomy for tractional retinal detachment secondary to proliferative diabetic retinopathy, exudative or tractional retinal detachment secondary to macular degeneration, macular hole or neovascular glaucoma.
Read the detailed description
This is an open-label, pilot study of intravitreally administered ranibizumab in subjects undergoing pars plana vitrectomy (PPV) to repair tractional retinal detachment secondary to proliferative diabetic retinopathy, exudative serous retinal detachment, macular hole or neovascular glaucoma.
Consented, enrolled subjects will be eligible to receive a single open-label intravitreal injection of 0.5 mg ranibizumab administered prior to undergoing PPV if in the Retinal Specialists opinion there could be a benefit to the disease or procedure from ranibizumab therapy.
The proposed study will analyze aqueous humor and vitreous samples drawn at the same time during vitrectomy to evaluate the levels of growth factors, cytokines and chemokines from patients undergoing planned pars plana vitrectomy as part of their retinal care. For patients receiving ranibizumab, serum samples will also be collected to assess PK. Patients will be split into three groups based on diagnosis: Group 1: (ranibizumab) proliferative diabetic retinopathy (tractional retinal detachment), macular degeneration with exudative or tractional retinal detachment, macular hole or neovascular glaucoma. Group 1 may receive one injection of intravitreal ranibizumab 0.5mg prior to vitrectomy. The injection will be administered at least 1-14 days prior to vitrectomy. Group 2 will serve as the control group and will not receive intravitreal ranibizumab prior to surgery.
Aqueous humor, vitreous and serum samples will be obtained to measure and compare growth factor, cytokine, chemokine levels and ranibizumab levels (if received). Undiluted core vitreous biopsies will be taken at the start of victrectomy. Aproximately 1 mL of undiluted vitreous fluid will be obtained with a closed infusion line and by manual aspiration with cutting on through the vitrectomy probe into a 2.5 mL syringe connected along the aspiration line. The sample will be frozen immediately and stored at -80°C.
Approximately 100 microliters of aqueous humor will be collected prior to the start of vitrectomy through anterior chamber paracentesis in the peripheral clear cornea using a 27 gauge needle on a tuberculin microsyringe from the central papillary area. Aqueous is transferred to a vial and placed in liquid nitrogen upon removal from the anterior chamber. Aqueous humor samples are immediately frozen at -80°C within 2 hours of collection until transferred to outside laboratories for further analysis.
Serum samples will be obtained from patients in Group 1 at baseline (Day 0) prior to treatment with intravitreal ranibizumab and on the day of surgery prior to the start of vitrectomy. Serum samples will be processed according to Genentech standard operating procedures and samples will be frozen immediately at -80C until analysis is ready to begin.
- Conditions
- Proliferative Diabetic Retinopathy, Macular Degeneration, Macular Hole, Neovascular Glaucoma
- Being tested
- Ranibizumab, No Ranibizumab
- Keywords
- Tractional retinal detachment, Exudative retinal detachment, Macular hole, Neovascular glaucoma
- Medical subject headings
- Macular Degeneration, Retinal Perforations, Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Subjects in the Ranibizumab arm will receive an injection of drug within 2 weeks prior to their surgery.
No RanibizumabOther
Subjects in the control arm will NOT receive an injection of drug within 2 weeks prior to their surgery.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Active comparator | Subjects undergoing surgery for neovascular glaucoma, diabetic retinopathy, or tractional Retinal Detachment due to AMD will receive one intravitreal injection of ranibizumab within 2 weeks of their surgery. Vitreous and aqueous humor samples will be collected during the surgery. Serum samples may be collected before, during, or after surgery. Receives: Drug: Ranibizumab |
| Control | Placebo comparator | Subjects undergoing surgery for ERM or macular hole will NOT receive an injection of ranibizumab, but will have vitreous, and aqueous humor samples collected during surgery (no serum collection). Receives: Other: No Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine Levels
Growth factor, cytokine, chemokine , and ranibizumab (if applicable) concentration in aqueous and vitreous samples collected during pars plana vitrectomy
Measured: Collected at Baseline
Secondary outcomes (1)
Serum Pharmacokinetics
Serum pharmacokinetic levels following a single intravitreal ranibizumab injection.
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startJul 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Retina Consultants
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Avery, California Retina Consultants
- Investigators
- Robert L Avery, MD, Principal investigator, California Retina Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067013
- Sponsor's protocol ID
- ML28894s
- Acronym
- ARK
- Status last verified
- Feb 2017
- First submitted
- 17 Feb 2014
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Vitreous and Aqueous Humor for Ocular Growth Factors, Cytokines, Chemokines, and Ranibizumab Pharmacokinetics Associated With Various Retinal Disease
- ClinicalTrials.gov ID
- NCT02067013
- Acronym / sponsor ID
- ARK / ML28894s
- Conditions
- Proliferative Diabetic Retinopathy, Macular Degeneration, Macular Hole, Neovascular Glaucoma
- Keywords
- Tractional retinal detachment, Exudative retinal detachment, Macular hole, Neovascular glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- California Retina ConsultantsUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 20 Feb 2014 (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.
Clinical Retina research studies often collect aqueous samples in hopes of estimating levels of drug or cytokines in the vitreous. Little is known about how well vitreous and aqueous correlate. This study will collect vitreous and aqueous samples at the same time to evaluate and compare drug and cytokine levels.
The overall objective of this study is to evaluate the molecular concentration of growth factors, cytokines and chemokines in human aqueous humor and vitreous samples collected from individuals undergoing pars plana vitrectomy for tractional retinal detachment secondary to proliferative diabetic retinopathy, exudative or tractional retinal detachment secondary to macular degeneration, macular hole or neovascular glaucoma.
Detailed description
This is an open-label, pilot study of intravitreally administered ranibizumab in subjects undergoing pars plana vitrectomy (PPV) to repair tractional retinal detachment secondary to proliferative diabetic retinopathy, exudative serous retinal detachment, macular hole or neovascular glaucoma.
Consented, enrolled subjects will be eligible to receive a single open-label intravitreal injection of 0.5 mg ranibizumab administered prior to undergoing PPV if in the Retinal Specialists opinion there could be a benefit to the disease or procedure from ranibizumab therapy.
The proposed study will analyze aqueous humor and vitreous samples drawn at the same time during vitrectomy to evaluate the levels of growth factors, cytokines and chemokines from patients undergoing planned pars plana vitrectomy as part of their retinal care. For patients receiving ranibizumab, serum samples will also be collected to assess PK. Patients will be split into three groups based on diagnosis: Group 1: (ranibizumab) proliferative diabetic retinopathy (tractional retinal detachment), macular degeneration with exudative or tractional retinal detachment, macular hole or neovascular glaucoma. Group 1 may receive one injection of intravitreal ranibizumab 0.5mg prior to vitrectomy. The injection will be administered at least 1-14 days prior to vitrectomy. Group 2 will serve as the control group and will not receive intravitreal ranibizumab prior to surgery.
Aqueous humor, vitreous and serum samples will be obtained to measure and compare growth factor, cytokine, chemokine levels and ranibizumab levels (if received). Undiluted core vitreous biopsies will be taken at the start of victrectomy. Aproximately 1 mL of undiluted vitreous fluid will be obtained with a closed infusion line and by manual aspiration with cutting on through the vitrectomy probe into a 2.5 mL syringe connected along the aspiration line. The sample will be frozen immediately and stored at -80°C.
Approximately 100 microliters of aqueous humor will be collected prior to the start of vitrectomy through anterior chamber paracentesis in the peripheral clear cornea using a 27 gauge needle on a tuberculin microsyringe from the central papillary area. Aqueous is transferred to a vial and placed in liquid nitrogen upon removal from the anterior chamber. Aqueous humor samples are immediately frozen at -80°C within 2 hours of collection until transferred to outside laboratories for further analysis.
Serum samples will be obtained from patients in Group 1 at baseline (Day 0) prior to treatment with intravitreal ranibizumab and on the day of surgery prior to the start of vitrectomy. Serum samples will be processed according to Genentech standard operating procedures and samples will be frozen immediately at -80C until analysis is ready to begin.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Active comparator | Drug: RanibizumabSubjects undergoing surgery for neovascular glaucoma, diabetic retinopathy, or tractional Retinal Detachment due to AMD will receive one intravitreal injection of ranibizumab within 2 weeks of their surgery. Vitreous and aqueous humor samples will be collected during the surgery. Serum samples may be collected before, during, or after surgery. |
| Control | Placebo comparator | Other: No RanibizumabSubjects undergoing surgery for ERM or macular hole will NOT receive an injection of ranibizumab, but will have vitreous, and aqueous humor samples collected during surgery (no serum collection). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Subjects with a diagnosis of tractional retinal detachment secondary to proliferative diabetic retinopathy, age-related macular degeneration with tractional or exudative retinal detachment, macular hole, epiretinal membrane, or neovascular glaucoma.
Key exclusion criteria (7 listed)
- Subjects with history of vitrectomy in the study eye
- Presence of vitreous hemorrhage
- Subjects with history of laser photocoagulation in the study eye within 3 months of vitrectomy
- Subjects unwilling to undergo pars plana vitrectomy
- Subjects unwilling to receive intravitreal ranibizumab prior to pars plana vitrectomy unless diagnosis of macular hole or epiretinal membrane
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 |
|---|---|---|
| RanibizumabAlso: LucentisSubjects in the Ranibizumab arm will receive an injection of drug within 2 weeks prior to their surgery. | Drug | Ranibizumab |
| No RanibizumabSubjects in the control arm will NOT receive an injection of drug within 2 weeks prior to their surgery. | Other | Control |
Primary outcome
Cytokine Levels
Time frame: Collected at Baseline
Growth factor, cytokine, chemokine , and ranibizumab (if applicable) concentration in aqueous and vitreous samples collected during pars plana vitrectomy
1 secondary outcome
Serum Pharmacokinetics
Time frame: Up to Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
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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.
Robert L Avery, MD principal investigator
California Retina Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranibizumab and No Ranibizumab in people with Proliferative Diabetic Retinopathy and Macular Degeneration, run by California Retina Consultants 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 3 inclusion and 7 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 1 Mar 2017. 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Gordon, PhD (805-963-1648 ext. 3034, gabe@californiaretina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine Levels (time frame: Collected at Baseline). 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 1 Mar 2017.