Retinal DiseasesPhase 2HD-LIPTNCT01205035
High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia
A Phase 2 study testing ranibizumab 2.0mg in people with Retinal Diseases and Telangiectasis, run by Eye Center of Northern Colorado, P.C. at 1 site in United States.
Trial summary
Idiopathic Parafoveal Telangiectasia (IPT) [also known as Idiopathic Perifoveal Telangiectasia, Idiopathic Juxtafoveal Telangiectasia (IJT, JFT) and Macular Telangiectasia (MacTel)] is a disorder of unknown etiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Diseases, Telangiectasis
- What is being tested?
- ranibizumab 2.0mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2012
- Phase
- Phase 2
- 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
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Presence of nonproliferative IPT confirmed by fluorescein angiography and spectral-domain OCT
- Age greater than 18
- Vision equal to or worse than 20/25 and better than or equal to 20/400 by ETDRS chart, without co-existing choroidal neovascularization.
- Physical ability and reasonable expectation to maintain all follow-up appointments.
Who cannot join
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- 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 ophthalmologic investigation or trial
- Any patient with proliferative diabetic retinopathy, diabetic macular edema, uveitis, history of ocular trauma, severe glaucoma, neovascular age-related macular degeneration
- Duration of previous treatment of IPT that exceeds two years.
Show all 14Show fewer
- Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either:
- Require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or
- If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of Best Corrected Visual Acuity (BCVA) over the study period
- Prior/Concomitant Treatment:
- Previous steroids (oral) within 30 days preceding Day 0
- Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)
- Prior participation in a Genentech ranibizumab clinical trial within 60 days.
- History of receiving intravitreal injections of ranibizumab, bevacizumab, pegaptanib, or any other intravitreal medication within 60 days of first injection. History of receiving intravitreal or subtenons triamcinolone within 90 days of first injection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Center of Northern Colorado
Fort Collins, Colorado, 80525
About this study
Official title: High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia [HD-LIPT]
Idiopathic Parafoveal Telangiectasia (IPT) [also known as Idiopathic Perifoveal Telangiectasia, Idiopathic Juxtafoveal Telangiectasia (IJT, JFT) and Macular Telangiectasia (MacTel)] is a disorder of unknown etiology. IPT is classified as Group 2A in the Gass classification of macular telangiectasias (Reference 1,5) - a bilateral, but not always symmetric disorder. It is characterized in its early stages by dilation and loss of parafoveal capillaries accompanied by angiographic leakage, "right angle" venules, central and parafoveal intraretinal cysts.
Read the detailed description
DESCRIPTION OF THE STUDY
This is an open-label, Phase I/II study of intravitreally administered ranibizumab in subjects with nonproliferative Idiopathic Parafoveal Telangiectasia (IPT).
Consented, enrolled subjects will be randomized into two groups: observation and treatment. The observation group will be monitored monthly while the treatment group will receive three open-label intravitreal injections of 1.0 mg ranibizumab administered every 30 days for 3 months and then as needed monthly, based on defined criteria. NOTE: The original protocol had the treatment group dosed at 2.0 mg/0.05mL. However, the 2.0mg dose will become unavailable beginning January 31, 2012. Therefore, the protocol amendment submitted in December 2011 changed the 2.0mg arm to a 1.0mg/ 0.10mL arm. Please note that three patients were already treated with 2.0mg before the amendment was submitted, so they will be switched to 1.0mg if they have not completed the study when the 2.0 dose is no longer available in January 2012.
Protocol: FVF4875s Final 6/P
29MAR2010
3.2
RATIONALE FOR STUDY DESIGN
As IPT is a chronically progressive condition, the purpose of this study is to see if high-dose ranibizumab can slow or stop the leakage and growth of existing, dilated, macular vessels in cases where no co-existing neovascularization exists as defined by fluorescein angiography and Ocular Coherence Tomography (OCT). Other outcomes include stabilization of visual acuity compared to observation group (defined by best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) measurements), and changes in ultrastructural features, as defined by OCT,
3.3
OUTCOME MEASURES
3.3.1 Primary Outcome Measures
To compare the change in visual acuity from baseline to one year in patients with nonproliferative IPT who are either treated with high-dose (1.0mg) ranibizumab or observed.
3.3.2 Secondary Outcome Measures
- To compare the change in visual acuity from baseline to 6 months and 9 months in patients with nonproliferative IPT who are either treated with high- dose (1.0mg) ranibizumab or observed. ii. To assess OCT changes in standard Central Subfield Thickness (CST) from baseline to 6 months, 9 months and 12 months. iii. To assess safety of administering 1.0mg ranibizumab (Lucentis) in patients with nonproliferative IPT at 6 months, 9 months and 12 months. iv. To assess changes in angiographic leakage from baseline at 6 and 12 months.
- Conditions
- Retinal Diseases, Telangiectasis
- Being tested
- ranibizumab 2.0mg
- Keywords
- Idiopathic Parafoveal Telangiectasia, Macular Telangiectasia, Macula Lutea/pathology, Retinal Diseases/pathology, Retinal Pigments/metabolism, Telangiectasis/metabolism, Telangiectasis/pathology
- Medical subject headings
- Retinal Diseases, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumab 2.0mgDrug
Also called Lucentis
Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Observation; No treatment given |
| Intravitreal ranibizumab 2.0mg | Experimental | Initial dose 2.0mg switched to 1.0mg at near conclusion of study. Receives: Drug: ranibizumab 2.0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity Change From Baseline to Month 12 of the Study
Measured: Baseline to 12 months
Secondary outcomes (4)
Change in Visual Acuity From Baseline to Month 6 and From Baseline to 9 Months
Measured: Baseline to 6 months and baseline to 9 months
Change in Standard Central Subfield Thickness (CST) as Measured by OCT From Baseline to 6, 9, and 12 Months
A large decrease in CST thickness may be indicative of a worse clinical outcome. These measurements are done to ensure safety of the participants.
Measured: Baseline to 6, 9, and 12 months
Number of Adverse Events Associated to the Administration of Ranibizumab 2.0mg
Measured: Baseline to 6 month, baseline to 9 month and baseline to 12 months
Angiographic Leakage From Baseline to Month 6 and 12
Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 6. Also any decreases of angiographic leakage was counted between baseline and 6 month. The same was done between baseline and 12 month.
Any increase of angiographic leakage was counted as a +1. Likewise, any decrease of angiographic leakage was counted as a -1. The sum was calculated based on the number of participants in each arm and the total shown in the outcome. For example: if across the three injected participants for their 6 month visit, two of them showed an increase of angiographic leakage and one showed a decrease, then the outcome would be, (+1) + (+1) + (-1)= +1. Likewise, if the same three participant's 12 month visit showed two with a decrease in leakage and one with no changes in leakage, the outcome would be, (-1) + (-1) + (0)= -2
Measured: Baseline to 6 and baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 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 Retinal DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye Center of Northern Colorado, P.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Arthur Korotkin, M.D., Eye Center of Northern Colorado, P.C.
- Investigators
- Arthur Korotkin, M.D., Principal investigator, Eye Center of Northern Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205035
- Sponsor's protocol ID
- FVF4875s
- Acronym
- HD-LIPT
- Status last verified
- Mar 2015
- First submitted
- 16 Sep 2010
- Last updated
- 10 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia [HD-LIPT]
- ClinicalTrials.gov ID
- NCT01205035
- Acronym / sponsor ID
- HD-LIPT / FVF4875s
- Conditions
- Retinal Diseases, Telangiectasis
- Keywords
- Idiopathic Parafoveal Telangiectasia, Macular Telangiectasia, Macula Lutea/pathology, Retinal Diseases/pathology, Retinal Pigments/metabolism, Telangiectasis/metabolism, Telangiectasis/pathology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Eye Center of Northern Colorado, P.C.University, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Posted 10 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Idiopathic Parafoveal Telangiectasia (IPT) [also known as Idiopathic Perifoveal Telangiectasia, Idiopathic Juxtafoveal Telangiectasia (IJT, JFT) and Macular Telangiectasia (MacTel)] is a disorder of unknown etiology. IPT is classified as Group 2A in the Gass classification of macular telangiectasias (Reference 1,5) - a bilateral, but not always symmetric disorder. It is characterized in its early stages by dilation and loss of parafoveal capillaries accompanied by angiographic leakage, "right angle" venules, central and parafoveal intraretinal cysts.
Detailed description
DESCRIPTION OF THE STUDY
This is an open-label, Phase I/II study of intravitreally administered ranibizumab in subjects with nonproliferative Idiopathic Parafoveal Telangiectasia (IPT).
Consented, enrolled subjects will be randomized into two groups: observation and treatment. The observation group will be monitored monthly while the treatment group will receive three open-label intravitreal injections of 1.0 mg ranibizumab administered every 30 days for 3 months and then as needed monthly, based on defined criteria. NOTE: The original protocol had the treatment group dosed at 2.0 mg/0.05mL. However, the 2.0mg dose will become unavailable beginning January 31, 2012. Therefore, the protocol amendment submitted in December 2011 changed the 2.0mg arm to a 1.0mg/ 0.10mL arm. Please note that three patients were already treated with 2.0mg before the amendment was submitted, so they will be switched to 1.0mg if they have not completed the study when the 2.0 dose is no longer available in January 2012.
Protocol: FVF4875s Final 6/P
29MAR2010
3.2
RATIONALE FOR STUDY DESIGN
As IPT is a chronically progressive condition, the purpose of this study is to see if high-dose ranibizumab can slow or stop the leakage and growth of existing, dilated, macular vessels in cases where no co-existing neovascularization exists as defined by fluorescein angiography and Ocular Coherence Tomography (OCT). Other outcomes include stabilization of visual acuity compared to observation group (defined by best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) measurements), and changes in ultrastructural features, as defined by OCT,
3.3
OUTCOME MEASURES
3.3.1 Primary Outcome Measures
To compare the change in visual acuity from baseline to one year in patients with nonproliferative IPT who are either treated with high-dose (1.0mg) ranibizumab or observed.
3.3.2 Secondary Outcome Measures
- To compare the change in visual acuity from baseline to 6 months and 9 months in patients with nonproliferative IPT who are either treated with high- dose (1.0mg) ranibizumab or observed. ii. To assess OCT changes in standard Central Subfield Thickness (CST) from baseline to 6 months, 9 months and 12 months. iii. To assess safety of administering 1.0mg ranibizumab (Lucentis) in patients with nonproliferative IPT at 6 months, 9 months and 12 months. iv. To assess changes in angiographic leakage from baseline at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –Observation; No treatment given |
| Intravitreal ranibizumab 2.0mg | Experimental | Drug: ranibizumab 2.0mgInitial dose 2.0mg switched to 1.0mg at near conclusion of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Presence of nonproliferative IPT confirmed by fluorescein angiography and spectral-domain OCT
- Age greater than 18
- Vision equal to or worse than 20/25 and better than or equal to 20/400 by ETDRS chart, without co-existing choroidal neovascularization.
Key exclusion criteria (14 listed)
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- 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 ophthalmologic investigation or trial
- Any patient with proliferative diabetic retinopathy, diabetic macular edema, uveitis, history of ocular trauma, severe glaucoma, neovascular age-related macular degeneration
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 |
|---|---|---|
| ranibizumab 2.0mgAlso: LucentisBaseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections | Drug | Intravitreal ranibizumab 2.0mg |
Primary outcome
Visual Acuity Change From Baseline to Month 12 of the Study
Time frame: Baseline to 12 months
4 secondary outcomes
Change in Visual Acuity From Baseline to Month 6 and From Baseline to 9 Months
Time frame: Baseline to 6 months and baseline to 9 months
Change in Standard Central Subfield Thickness (CST) as Measured by OCT From Baseline to 6, 9, and 12 Months
Time frame: Baseline to 6, 9, and 12 months
Number of Adverse Events Associated to the Administration of Ranibizumab 2.0mg
Time frame: Baseline to 6 month, baseline to 9 month and baseline to 12 months
Angiographic Leakage From Baseline to Month 6 and 12
Time frame: Baseline to 6 and baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Arthur Korotkin, M.D. principal investigator
Eye Center of Northern Colorado
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 2.0mg in people with Retinal Diseases and Telangiectasis, run by Eye Center of Northern Colorado, P.C. 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 6 inclusion and 14 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 10 Apr 2015. 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 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?
Yes. Results are posted in the registry (first posted 10 Apr 2015). 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?
Visual Acuity Change From Baseline to Month 12 of the Study (time frame: Baseline to 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 10 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.