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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Arthur Korotkin, M.D., Eye Center of Northern Colorado, P.C.
ClinicalTrials.gov Identifier:
NCT01205035
First received: September 16, 2010
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Retinal Diseases
Telangiectasis
Drug: ranibizumab 2.0mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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]

Resource links provided by NLM:


Further study details as provided by Eye Center of Northern Colorado, P.C.:

Primary Outcome Measures:
  • Visual acuity change from baseline to month 12 of the study [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in visual acuity from baseline to month 6 and 9 [ Time Frame: 6 and 9 months ] [ Designated as safety issue: No ]
  • Macular OCT changes from baseline to 6, 9, and 12 months [ Time Frame: 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • To assess safety of administration of ranibizumab 2.0mg [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To assess angiographic changes from baseline to month 6 and 12 [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Observation
Observation
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

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 OCT. Other outcomes include stabilization of visual acuity compared to observation group (defined by best corrected 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205035

Locations
United States, Colorado
Eye Center of Northern Colorado
Fort Collins, Colorado, United States, 80525
Sponsors and Collaborators
Eye Center of Northern Colorado, P.C.
Genentech, Inc.
Investigators
Principal Investigator: Arthur Korotkin, M.D. Eye Center of Northern Colorado
  More Information

No publications provided

Responsible Party: Arthur Korotkin, M.D., M.D., Eye Center of Northern Colorado, P.C.
ClinicalTrials.gov Identifier: NCT01205035     History of Changes
Other Study ID Numbers: FVF4875s
Study First Received: September 16, 2010
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Eye Center of Northern Colorado, P.C.:
Idiopathic Parafoveal Telangiectasia
Macular Telangiectasia
Macula Lutea/pathology
Retinal Diseases/pathology
Retinal Pigments/metabolism
Telangiectasis/metabolism
Telangiectasis/pathology

Additional relevant MeSH terms:
Retinal Diseases
Telangiectasis
Cardiovascular Diseases
Eye Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014