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High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia (HD-LIPT)

Primary Purpose

Retinal Diseases, Telangiectasis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ranibizumab 2.0mg

About this trial

This is an interventional treatment trial for Retinal Diseases focused on measuring Idiopathic Parafoveal Telangiectasia, Macular Telangiectasia, Macula Lutea/pathology, Retinal Diseases/pathology, Retinal Pigments/metabolism, Telangiectasis/metabolism, Telangiectasis/pathology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Eye Center of Northern Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observation

Intravitreal ranibizumab 2.0mg

Arm Description

Observation; No treatment given

Initial dose 2.0mg switched to 1.0mg at near conclusion of study.

Outcomes

Primary Outcome Measures

Visual Acuity Change From Baseline to Month 12 of the Study

Secondary Outcome Measures

Change in Visual Acuity From Baseline to Month 6 and From 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.

Number of Adverse Events Associated to the Administration of Ranibizumab 2.0mg

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

Full Information

NCT ID

NCT01205035

First Posted

September 16, 2010

Last Updated

March 30, 2015

Sponsor

Eye Center of Northern Colorado, P.C.

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01205035

Brief Title

High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia

Acronym

HD-LIPT

Official Title

High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia [HD-LIPT]

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eye Center of Northern Colorado, P.C.

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Diseases, Telangiectasis

Keywords

Idiopathic Parafoveal Telangiectasia, Macular Telangiectasia, Macula Lutea/pathology, Retinal Diseases/pathology, Retinal Pigments/metabolism, Telangiectasis/metabolism, Telangiectasis/pathology

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Observation

Arm Type

No Intervention

Arm Description

Observation; No treatment given

Arm Title

Intravitreal ranibizumab 2.0mg

Arm Type

Experimental

Arm Description

Initial dose 2.0mg switched to 1.0mg at near conclusion of study.

Intervention Type

Drug

Intervention Name(s)

ranibizumab 2.0mg

Other Intervention Name(s)

Lucentis

Intervention Description

Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections

Primary Outcome Measure Information:

Title

Visual Acuity Change From Baseline to Month 12 of the Study

Time Frame

Baseline to 12 months

Secondary Outcome Measure Information:

Title

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

Title

Change in Standard Central Subfield Thickness (CST) as Measured by OCT From Baseline to 6, 9, and 12 Months

Description

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

Title

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

Title

Angiographic Leakage From Baseline to Month 6 and 12

Description

Time Frame

Baseline to 6 and baseline to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arthur Korotkin, M.D.

Organizational Affiliation

Eye Center of Northern Colorado

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eye Center of Northern Colorado

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80525

Country

United States

12. IPD Sharing Statement

Learn more about this trial

High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia

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