High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia (HD-LIPT)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia [HD-LIPT]|
- Visual Acuity Change From Baseline to Month 12 of the Study [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]A large decrease in CST thickness may be indicative of a worse clinical outcome. These measurements are done to ensure safety of the participants.
- 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 ] [ Designated as safety issue: No ]
- Angiographic Leakage From Baseline to Month 6 and 12 [ Time Frame: Baseline to 6 and baseline to 12 months ] [ Designated as safety issue: No ]
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
|Study Start Date:||October 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
No Intervention: Observation
Observation; No treatment given
Experimental: Intravitreal ranibizumab 2.0mg
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
Other Name: Lucentis
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
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,
3.3.1 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205035
|United States, Colorado|
|Eye Center of Northern Colorado|
|Fort Collins, Colorado, United States, 80525|
|Principal Investigator:||Arthur Korotkin, M.D.||Eye Center of Northern Colorado|