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

NCT01205035 | Completed Phase 2 Results DMC

• 1 other identifier: FVF4875s
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Diseases; Telangiectasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Visual Acuity Change From Baseline to Month 12 of the Study

  Baseline to 12 months

Secondary Outcomes (4)

• Change in Visual Acuity From Baseline to Month 6 and From Baseline to 9 Months

  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

  Baseline to 6, 9, and 12 months

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

  Baseline to 6 month, baseline to 9 month and baseline to 12 months

• Angiographic Leakage From Baseline to Month 6 and 12

  Baseline to 6 and baseline to 12 months

Study Arms (2)

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.

Drug: ranibizumab 2.0mg

Interventions

ranibizumab 2.0mg DRUG

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

Intravitreal ranibizumab 2.0mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye Center of Northern Colorado, P.C.: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Eye Center of Northern Colorado

Fort Collins, Colorado, 80525, United States

Location

MeSH Terms

Conditions

Retinal Diseases; Telangiectasis

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Arthur Korotkin, MD
• Organization: Eye Center of Northern Colorado, PC

retina@eyecenternoco.com

970-221-2222

Study Officials

• Arthur Korotkin, M.D.

  Eye Center of Northern Colorado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 20, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 10, 2015
• Results First Posted: April 10, 2015

Record last verified: 2015-03

Locations

US (1)