Choroidal NeovascularizationPhase 1NCT00363168
Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
A Phase 1 study testing Ranibizumab in people with Choroidal Neovascularization, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Choroidal Neovascularization
- What is being tested?
- Ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to May 2009
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Predominantly hemorrhagic subfoveal CNV (at least 50% of the lesion composed of hemorrhage) from age-related macular degeneration (AMD) resulting in visual acuity of 20/40 or worse.
- Age greater than 50 years.
- Participant must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Known hypersensitivity to humanized monoclonal antibodies
- History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment).
- History of stroke within 6 months of study entry.
- Current acute ocular or periocular infection.
- Any major surgical procedure within one month of study entry.
Show all 13Show fewer
- Known serious allergies to fluorescein dye.
- Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months.
- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months.
- History of subfoveal laser treatment in the study eye.
- History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than AMD in the study eye.
- Ocular inflammation (including trace or above) in the study eye.
- Inability to comply with study or follow up procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland, 21287
About this study
This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration.
A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition.
Read the detailed description
This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab, which will be performed monthly for 3 doses. Further monthly injections are at the discretion of the examiner, and may be withheld if there is lack of continued improvement (defined as lack of improvement of at least 5 letters on an eye chart compared with 2 previous consecutive visits or lack of decrease of the retinal center point thickness of at least 50 microns compared with 2 previous consecutive visits) or complete success (defined as visual acuity of 20/20 or better or retinal center point thickness <225 microns).
- Conditions
- Choroidal Neovascularization
- Being tested
- Ranibizumab
- Keywords
- Hemorrhagic Choroidal Neovascularization
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
0.3 mg/0.05 ml dose
RanibizumabDrug
Also called Lucentis
0.5 mg/0.05 ml dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 0.3 mg/0.05 ml dose of ranibizumab Receives: Drug: Ranibizumab |
| B | Experimental | 0.5 mg/0.05 ml dose of ranibizumab Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.
Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.
Measured: 12 months
Secondary outcomes (4)
Retinal Changes on Funduscopy
Measured: 12 months
Retinal Thickness Measured by Optical Coherence Tomography (OCT)
Measured: 12 months
Fluorescein Leakage on Fluorescein Angiography
Measured: 12 months
Number of Subjects Experiencing Complications Related to Drug or Its Administration
Potential complications included:
- Deterioration of best-corrected visual acuity by 3 or more lines
- Development of intraocular inflammation
- Development of elevated intraocular pressure
- Development of other ocular or systemic adverse effects.
Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function.
Measured: 12 months after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2008
- Study completionMay 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Choroidal NeovascularizationStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Dr. Neil M. Bressler, Johns Hopkins University
- Investigators
- Neil M. Bressler, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363168
- Sponsor's protocol ID
- NA_00001650
- Status last verified
- Sep 2012
- First submitted
- 9 Aug 2006
- Last updated
- 19 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chang MA, Do DV, Bressler SB, Cassard SD, Gower EW, Bressler NM. Prospective one-year study of ranibizumab for predominantly hemorrhagic choroidal neovascular lesions in age-related macular degeneration. Retina. 2010 Sep;30(8):1171-6. doi: 10.1097/IAE.0b013e3181dd6d8a.
PubMed 20827138
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
- ClinicalTrials.gov ID
- NCT00363168
- Acronym / sponsor ID
- NA_00001650
- Conditions
- Choroidal Neovascularization
- Keywords
- Hemorrhagic Choroidal Neovascularization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 19 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration.
A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition.
Detailed description
This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab, which will be performed monthly for 3 doses. Further monthly injections are at the discretion of the examiner, and may be withheld if there is lack of continued improvement (defined as lack of improvement of at least 5 letters on an eye chart compared with 2 previous consecutive visits or lack of decrease of the retinal center point thickness of at least 50 microns compared with 2 previous consecutive visits) or complete success (defined as visual acuity of 20/20 or better or retinal center point thickness <225 microns).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Ranibizumab0.3 mg/0.05 ml dose of ranibizumab |
| B | Experimental | Drug: Ranibizumab0.5 mg/0.05 ml dose of ranibizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Predominantly hemorrhagic subfoveal CNV (at least 50% of the lesion composed of hemorrhage) from age-related macular degeneration (AMD) resulting in visual acuity of 20/40 or worse.
- Age greater than 50 years.
- Participant must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography.
Key exclusion criteria (13 listed)
- Known hypersensitivity to humanized monoclonal antibodies
- History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment).
- History of stroke within 6 months of study entry.
- Current acute ocular or periocular infection.
- Any major surgical procedure within one month 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 |
|---|---|---|
| RanibizumabAlso: Lucentis0.3 mg/0.05 ml dose | Drug | A |
| RanibizumabAlso: Lucentis0.5 mg/0.05 ml dose | Drug | B |
Primary outcome
Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.
Time frame: 12 months
Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.
4 secondary outcomes
Retinal Changes on Funduscopy
Time frame: 12 months
Retinal Thickness Measured by Optical Coherence Tomography (OCT)
Time frame: 12 months
Fluorescein Leakage on Fluorescein Angiography
Time frame: 12 months
Number of Subjects Experiencing Complications Related to Drug or Its Administration
Time frame: 12 months after last injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20827138Chang MA, Do DV, Bressler SB, Cassard SD, Gower EW, Bressler NM. Prospective one-year study of ranibizumab for predominantly hemorrhagic choroidal neovascular lesions in age-related macular degeneration. Retina. 2010 Sep;30(8):1171-6. doi: 10.1097/IAE.0b013e3181dd6d8a.
Related trials for Choroidal Neovascularization
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
Active, not recruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Age-Related Macular Degeneration
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.
Neil M. Bressler, MD principal investigator
Johns Hopkins University
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 Choroidal Neovascularization, run by Johns Hopkins University 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 13 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 19 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 19 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?
Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters. (time frame: 12 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 NCT00363168, 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 19 Oct 2012.