Diabetic Macular EdemaPhase 1CAPTURENCT00676559
Combined aPproach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study
A Phase 1 study testing Efalizumab and Ranibizumab in people with Diabetic Macular Edema, run by Johns Hopkins University at 10 sites in United States.
Trial summary
This study looks to continue the study of anti-vegf therapy in patients with macular edema, and compare it to an anti-inflammatory therapy and a combined Anti-vegf and anti-inflammatory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Efalizumab and Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2008to Apr 2010
- Phase
- Phase 1
- 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
- Signed informed consent and authorization of use and disclosure of protected health information
- 18 years of Age
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Serum HbA1c 5.5% within 12 months of randomization
- Retinal thickening (diabetic macular edema) involving the center of the fovea
- Diagnosis must be confirmed by fluorescein angiography and OCT images over 250
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- Best corrected visual acuity score in the study eye of 20/40 to 20/320
- If a female of childbearing potential, a negative pregnancy test and commitment to the use of at least two forms of effective contraception.
- If a non-sterile male, commitment to the use of two forms of effective contraception.
- Demonstrate understanding of and ability to perform weekly self sub-cutaneous injections.
Who cannot join
- Panretinal or macular photocoagulation within 3 months of study entry in the study eye
- Use of intraocular or periocular injection of steroids in the study eye within 3 months of study entry
- Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry
- Current or history of prior treatment of psoriasis with subcutaneous efalizumab within 6 months of study entry
- Proliferative diabetic retinopathy in the study eye, with the exceptions of
- inactive, fibrotic proliferative diabetic retinopathy that has regressed following pan-retinal laser photocoagulation OR
Show all 30Show fewer
- tufts of neovascularization elsewhere (NVE) less than one disc area with no vitreous hemorrhage
- Vitreomacular traction or epiretinal membrane in the study eye
- Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
- Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the first 6-months.
- Cataract surgery in the study eye within 3 months of study entry; (YAG) laser capsulotomy within 1 month of study entry; or any other intraocular surgery within 3 months preceding Day 0.
- History of vitreoretinal surgery in the study eye within 3 months of study entry
- Uncontrolled glaucoma .
- Blood pressure exceeding 180/100 (sitting) during the screening period
- Uncontrolled diabetes mellitus, as evidenced by glycosylated hemoglobin > or = 13%(HbA1c) value
- Renal failure requiring dialysis or renal transplant
- Premenopausal women unwilling to commit to adequate contraception
- History of other diseases or finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications
- International Normalized Ratio (INR) > or = 3.0 (e.g. due to current treatment with warfarin).
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment.
- Have a history of hypersensitivity to efalizumab
- Have a history of ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. Have a history of opportunistic infections.
- Have the presence or history of malignancy, including lymphoproliferative disorders.
- Have a history of thrombocytopenia, clinically significant hemolytic anemia, or unexplained anemia
- Have a platelet count < 100,000 cells/microliter (uL)
- Inability to comply
- Patients receiving immunosuppressive agents
- All acellular, live and live-attenuated vaccines are excluded from 14 days prior to the first dose of efalizumab until a minimum of 4 weeks after the last dose of efalizumab
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- Participation in another simultaneous medical investigation or trial
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Texas Retina Associates
Arlington, Texas, 76012
Wilmer Eye Institute at the Johns Hopkins University
Baltimore, Maryland, 21287
Retina Associates of Maine
Bangor, Maine, 04401
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Eye Care Specialists
Kingston, Pennsylvania, 18704
University of Utah
Salt Lake City, Utah, 84132
Sharp Rees-Stealy Medical Group
San Diego, California, 92101
Retina Center of Maine
South Portland, Maine, 04106
Retina Macula Institute
Torrance, California, 90503
Diego H. Calonje, M.D., P.C.
Tucson, Arizona, 85712
About this study
This study looks to continue the study of anti-vegf therapy in patients with macular edema, and compare it to an anti-inflammatory therapy and a combined Anti-vegf and anti-inflammatory.
Read the detailed description
Cell adhesion molecules are key mediators of inflammatory processes, which have been shown to play a role in the pathogenesis of diabetic retinopathy . Efalizumab inhibits the binding of leukocyte function-associated antigen-1 (LFA-1) to intercellular adhesion molecule-1 (ICAM-1) thereby inhibiting the adhesion of leukocytes to other cell types.
Clinical studies have demonstrated the bioactivities of intravitreal ranibizumab, a Vascular endothelial growth factor (VEGF) antagonist, in reducing retinal thickness and improving visual acuity in patients with diabetic macular edema (DME).
The objective of the CAPTURE Study is to assess the safety and tolerability of efalizumab, administered subcutaneously as a weekly (1 mg/kg) dose, compared to and in combination with ranibizumab, administered intravitreally (0.5 mg), in the treatment of DME.
- Conditions
- Diabetic Macular Edema
- Being tested
- Efalizumab, Ranibizumab
- Keywords
- Diabetic, Macular, Edema, DME, Clinically Significant Macular Edema (CSME)
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfalizumabDrug
Also called Raptiva
Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks.
RanibizumabDrug
Also called Lucentis
Ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks. Receives: Drug: Efalizumab |
| Group 2 | Experimental | Ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive). Receives: Drug: Ranibizumab |
| Group 3 | Experimental | Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks in combination with ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive). Receives: Drug: Efalizumab; Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of efalizumab, compared to and in combination with ranibizumab, measuring the frequency and severity of adverse events.
Measured: 6 mos
Secondary outcomes (2)
To measure the mean change from Baseline to Month 6 and Month 12 in Best correct visual acuity (BCVA)
Measured: 6 and 12 mos.
To evaluate the anatomic retinal changes as assessed by color fundus photography, fluorescein angiography, and Optical Coherence Tomography (OCT)
Measured: 6 mos and 12 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009 (estimated)
- Study completionApr 2010 (estimated)
Why it stopped: Unrelated serious adverse events involving one of the proposed medications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Genentech, Inc.
- Investigators
- Quan Dong Nguyen, MD, MSc, Study director, Johns Hopkins UniversityDiana V Do, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676559
- Sponsor's protocol ID
- NA 00015499
- Acronym
- CAPTURE
- Status last verified
- Aug 2016
- First submitted
- 8 May 2008
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined aPproach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study
- ClinicalTrials.gov ID
- NCT00676559
- Acronym / sponsor ID
- CAPTURE / NA 00015499
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic, Macular, Edema, DME, Clinically Significant Macular Edema (CSME)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unrelated serious adverse events involving one of the proposed medications
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Genentech, Inc.
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 13 May 2008 (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.
This study looks to continue the study of anti-vegf therapy in patients with macular edema, and compare it to an anti-inflammatory therapy and a combined Anti-vegf and anti-inflammatory.
Detailed description
Cell adhesion molecules are key mediators of inflammatory processes, which have been shown to play a role in the pathogenesis of diabetic retinopathy . Efalizumab inhibits the binding of leukocyte function-associated antigen-1 (LFA-1) to intercellular adhesion molecule-1 (ICAM-1) thereby inhibiting the adhesion of leukocytes to other cell types.
Clinical studies have demonstrated the bioactivities of intravitreal ranibizumab, a Vascular endothelial growth factor (VEGF) antagonist, in reducing retinal thickness and improving visual acuity in patients with diabetic macular edema (DME).
The objective of the CAPTURE Study is to assess the safety and tolerability of efalizumab, administered subcutaneously as a weekly (1 mg/kg) dose, compared to and in combination with ranibizumab, administered intravitreally (0.5 mg), in the treatment of DME.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: EfalizumabEfalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks. |
| Group 2 | Experimental | Drug: RanibizumabRanibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive). |
| Group 3 | Experimental | Drug: Efalizumab, Drug: RanibizumabEfalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks in combination with ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent and authorization of use and disclosure of protected health information
- 18 years of Age
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Serum HbA1c 5.5% within 12 months of randomization
- Retinal thickening (diabetic macular edema) involving the center of the fovea
Key exclusion criteria (30 listed)
- Panretinal or macular photocoagulation within 3 months of study entry in the study eye
- Use of intraocular or periocular injection of steroids in the study eye within 3 months of study entry
- Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry
- Current or history of prior treatment of psoriasis with subcutaneous efalizumab within 6 months of study entry
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 |
|---|---|---|
| EfalizumabAlso: RaptivaEfalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks. | Drug | Group 1, Group 3 |
| RanibizumabAlso: LucentisRanibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive). | Drug | Group 2, Group 3 |
Primary outcome
To assess the safety and tolerability of efalizumab, compared to and in combination with ranibizumab, measuring the frequency and severity of adverse events.
Time frame: 6 mos
2 secondary outcomes
To measure the mean change from Baseline to Month 6 and Month 12 in Best correct visual acuity (BCVA)
Time frame: 6 and 12 mos.
To evaluate the anatomic retinal changes as assessed by color fundus photography, fluorescein angiography, and Optical Coherence Tomography (OCT)
Time frame: 6 mos and 12 mos
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
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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.
Quan Dong Nguyen, MD, MSc study director
Johns Hopkins University
Diana V Do, MD principal investigator
Johns Hopkins University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Efalizumab and Ranibizumab in people with Diabetic Macular Edema, run by Johns Hopkins University at 10 sites 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 10 inclusion and 30 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: withdrawn, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To assess the safety and tolerability of efalizumab, compared to and in combination with ranibizumab, measuring the frequency and severity of adverse events. (time frame: 6 mos). 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 26 Aug 2016.