A Phase 2 interventional study of ranibizumab 2.0mg in Retinal Diseases and Telangiectasis, sponsored by Eye Center of Northern Colorado, P.C.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-10.
Sponsored by Eye Center of Northern Colorado, P.C. · Phase 2, Interventional, and Treatment
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.
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
i. 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.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's enrollment of 6 is below the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →This is the only study on the registry with Eye Center of Northern Colorado, P.C. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Observation; No treatment given
Initial dose 2.0mg switched to 1.0mg at near conclusion of study.
Drug: ranibizumab 2.0mg
Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
Also known as: Lucentis
Visual Acuity Change From Baseline to Month 12 of the Study
Time frame: Baseline to 12 months
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
A large decrease in CST thickness may be indicative of a worse clinical outcome. These measurements are done to ensure safety of the participants.
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
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
Time frame: Baseline to 6 and baseline to 12 months
| Milestone | Observation | Intravitreal Ranibizumab 2.0mg |
|---|---|---|
| Started | 3 | 3 |
| Completed | 1 | 3 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| LogMAR Unit | Observation | Intravitreal Ranibizumab 2.0mg |
|---|---|---|
| Visual Acuity Change From Baseline to Month 12 of the Study | 0.1 (0.1 to 0.1) | -0.05 (-0.12 to 0) |
| LogMAR Unit | Observation | Intravitreal Ranibizumab 2.0mg |
|---|---|---|
| Baseline to 6 month | 0.04 (0.04 to 0.04) | -0.10 (-0.2 to -0.02) |
| Baseline to 9 month | 0.02 (0.02 to 0.02) | -0.12 (-0.14 to -0.08) |
A large decrease in CST thickness may be indicative of a worse clinical outcome. These measurements are done to ensure safety of the participants.
| Micrometer | Observation | Intravitreal Ranibizumab 2.0mg |
|---|---|---|
| Baseline to 6 month | -20 (-20 to -20) | 7 (-2 to 20) |
| Baseline to 9 month | -16 (-16 to -16) | -6 (-17 to 12) |
| Baseline to 12 month | -11 (-11 to -11) | -4 (-14 to 2) |
| Number of Adverse Events | Observation | Intravitreal Ranibizumab 2.0mg |
|---|---|---|
| Baseline to 6 month | 0 | 0 |
| Baseline to 9 month | 0 | 0 |
| Baseline to 12 month | 0 | 0 |
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
| Sum of increases (+1) and decreases (-1) | Observation | Intravitreal Ranibizumab 2.0mg |
|---|---|---|
| Baseline to 6 month | 0 | 1 |
| Baseline to 12 month | 0 | -2 |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Observation | — | 0/3 (0%) | 2/3 (66.7%) |
| Intravitreal Ranibizumab 2.0mg | — | 0/3 (0%) | 2/3 (66.7%) |
| Event | Observation | Intravitreal Ranibizumab 2.0mg |
|---|---|---|
| Elevated Blood PressureCardiac disorders | 0/3 | 1/3 |
| SinusitisInfections and infestations | 0/3 | 1/3 |
| ColdImmune system disorders | 1/3 | 0/3 |
| Food PoisoningGeneral disorders | 1/3 | 0/3 |
| DiabetesEndocrine disorders | 1/3 | 0/3 |
| Ear InfectionInfections and infestations | 1/3 | 0/3 |
| AllergiesRespiratory, thoracic and mediastinal disorders | 1/3 | 0/3 |
| Stiff NeckMusculoskeletal and connective tissue disorders | 1/3 | 0/3 |
| Age, Continuous(years) | Observation | Intravitreal Ranibizumab 2.0mg | Total |
|---|---|---|---|
| Mean | 68 (52 to 76) | 65 (52 to 76) | 66.5 (52 to 76) |
| Sex: Female, Male(Participants) | Observation | Intravitreal Ranibizumab 2.0mg | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 1 | 1 | 2 |
| Region of Enrollment(participants) | Observation | Intravitreal Ranibizumab 2.0mg | Total |
|---|---|---|---|
| United States | 3 | 3 | 6 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.