Rubeosis IridisPhase 1NCT01069341
Use of Ranibizumab to Treat Rubeosis in Diabetics Prior to Cataract Surgery
A Phase 1 study testing Ranibizumab in people with Rubeosis Iridis and Proliferative Diabetic Retinopathy, run by Bhagat, Neelakshi, M.D., M.P.H. at 1 site in United States.
Trial summary
The purpose of this study was to determine the safety of ranibizumab: a) as a surgical adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (PDR) induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (PDR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rubeosis Iridis, Proliferative Diabetic Retinopathy
- What is being tested?
- Ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jan 2012
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or over
- Subjects with diabetes mellitus
- Subjects with proliferative diabetic retinopathy induced rubeosis
- Be willing to undergo cataract surgery
- HgbA1c level < 12%
Who cannot join
- History of glaucoma surgery
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
- Intraocular surgery in the study eye within 60 days preceding Day 0
- History of prior pars plana vitrectomy in the study eye
- Positive pregnancy test
- HbA1c >12
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ranibizumab in Subjects With Dense Cataract and Rubeosis Due to Proliferative Diabetic Retinopathy (PDR)
The purpose of this study was to determine the safety of ranibizumab: a) as a surgical adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (PDR) induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (PDR).
Read the detailed description
This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in diabetic subjects presenting initially with dense cataract and proliferative diabetic retinopathy induced rubeosis. Ten subjects will be enrolled at a single center over a 10 month period. Patients will be followed for a total of 12 months in the treatment phase and will have safety follow-ups at Months 18 and 24. Eligibility for study entry will be determined by the principal investigator.
Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every month for 3 doses (loading dose on Day 0 and at Months 1 and 2) followed by as needed re-treatment based on specified criteria for the remainder of the study period. Subjects can receive a maximum of eight injections of ranibizumab during the study. All subjects will undergo cataract surgery after the first ranibizumab injection. Only one eye will be designated as the study eye for the duration of the study to receive the ranibizumab injections.
All subjects will be evaluated with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, intraocular pressure measurement, ophthalmological examination, slit lamp photography, gonioscopy, fundus photography, fundus fluorescein angiography and Optical Coherence Tomography (OCT). An ultrasound will be done as needed. Best corrected ETDRS visual acuity and intraocular pressure measurements will be performed on both eyes.
- Being tested
- Ranibizumab
- Keywords
- Rubeosis, Neovascularization of iris, Proliferative diabetic retinopathy, PDR, Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | All subjects enrolled received treatment with identical dosage of Ranibizumab Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE)
Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR).
Measured: first 12 months
Secondary outcomes (7)
Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)
Presence of neovascularization of iris (NVI) or neovascularization of the angle (NVA) as assessed by gonioscopy at months 3, 7 and 12
Measured: months 3, 7 and 12
Presence of Proliferative Diabetic Retinopathy (PDR)
Presence of proliferative diabetic retinopathy by fluorescein angiogram
Measured: at month-12
Macular Volume
Macular volume (millimeters cubed [mm3]) by Stratus OCT
Measured: at months-1,3,7, and 12
Mean Time to Re-treatment
Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months)
Measured: first 12 months
Mean Number of Ranibizumab Injections
Mean number of ranibizumab injections required through month 12
Measured: first 12 months
Mean Number of PRP Laser Treatments
Mean number of PRP laser treatments required through month 12
Measured: first 12 months
Mean Change in Intraocular Pressure (IOP)
Mean change in IOP (mm Hg) from baseline to months-3, 7, and 12.
Measured: at months-3,7, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startJul 2007
- Primary completionDec 2011
- Study completionJan 2012
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 Rubeosis IridisStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bhagat, Neelakshi, M.D., M.P.H.
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Neelakshi Bhagat, MD, MPH, Principal investigator, NJMS / UMDNJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069341
- Sponsor's protocol ID
- FVF 4297s
- Status last verified
- Sep 2012
- First submitted
- 15 Feb 2010
- Last updated
- 4 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab in Subjects With Dense Cataract and Rubeosis Due to Proliferative Diabetic Retinopathy (PDR)
- ClinicalTrials.gov ID
- NCT01069341
- Acronym / sponsor ID
- FVF 4297s
- Keywords
- Rubeosis, Neovascularization of iris, Proliferative diabetic retinopathy, PDR, Cataract
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bhagat, Neelakshi, M.D., M.P.H.
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Posted 4 Oct 2012
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 was to determine the safety of ranibizumab: a) as a surgical adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (PDR) induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (PDR).
Detailed description
This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in diabetic subjects presenting initially with dense cataract and proliferative diabetic retinopathy induced rubeosis. Ten subjects will be enrolled at a single center over a 10 month period. Patients will be followed for a total of 12 months in the treatment phase and will have safety follow-ups at Months 18 and 24. Eligibility for study entry will be determined by the principal investigator.
Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every month for 3 doses (loading dose on Day 0 and at Months 1 and 2) followed by as needed re-treatment based on specified criteria for the remainder of the study period. Subjects can receive a maximum of eight injections of ranibizumab during the study. All subjects will undergo cataract surgery after the first ranibizumab injection. Only one eye will be designated as the study eye for the duration of the study to receive the ranibizumab injections.
All subjects will be evaluated with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, intraocular pressure measurement, ophthalmological examination, slit lamp photography, gonioscopy, fundus photography, fundus fluorescein angiography and Optical Coherence Tomography (OCT). An ultrasound will be done as needed. Best corrected ETDRS visual acuity and intraocular pressure measurements will be performed on both eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Drug: RanibizumabAll subjects enrolled received treatment with identical dosage of Ranibizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or over
- Subjects with diabetes mellitus
- Subjects with proliferative diabetic retinopathy induced rubeosis
- Be willing to undergo cataract surgery
- HgbA1c level < 12%
Key exclusion criteria (6 listed)
- History of glaucoma surgery
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
- Intraocular surgery in the study eye within 60 days preceding Day 0
- History of prior pars plana vitrectomy in the study eye
- Positive pregnancy test
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: LucentisIntravitreally administered 0.5mg ranibizumab, 3 doses administered monthly. | Drug | Treatment |
Primary outcome
Adverse Event (AE)
Time frame: first 12 months
Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR).
7 secondary outcomes
Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)
Time frame: months 3, 7 and 12
Presence of Proliferative Diabetic Retinopathy (PDR)
Time frame: at month-12
Macular Volume
Time frame: at months-1,3,7, and 12
Mean Time to Re-treatment
Time frame: first 12 months
Mean Number of Ranibizumab Injections
Time frame: first 12 months
Mean Number of PRP Laser Treatments
Time frame: first 12 months
Mean Change in Intraocular Pressure (IOP)
Time frame: at months-3,7, and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Neelakshi Bhagat, MD, MPH principal investigator
NJMS / UMDNJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ranibizumab in people with Rubeosis Iridis and Proliferative Diabetic Retinopathy, run by Bhagat, Neelakshi, M.D., M.P.H. 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 5 inclusion and 6 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 4 Oct 2012. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2012). 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?
Adverse Event (AE) (time frame: first 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 4 Oct 2012.