HiPED - High Dose Lucentis for Persistent Pigment Epithelial Detachments in Age-related Macular Degeneration

Macular Degeneration Clinical Trial

— HiPED  

Official title:

High Dose Lucentis for Persistent Pigment Epithelial Detachment in Neovascular Age-related Macular Degeneration - The HiPED Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01189019
• Other study ID #: FVF4928
• Status: Terminated
• Phase: Phase 2
• First received: August 24, 2010
• Last updated: March 28, 2016
• Start date: August 2010
• Est. completion date: March 2013

Study information

• Verified date: March 2016
• Source: Pacific Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

In this fifth year of anti-VEGF therapy for neovascular AMD, retinal physicians are collecting groups of patients who either do not or only partially respond to anti-VEGF therapy. This study will evaluate the efficacy and safety of 2mg ranibizumab specifically for patients with fibrovascular PEDs that have not resolved following at least 6 consecutive injections of ranibizumab or bevacizumab over the previous 12 months. The investigators hypothesize that the 2mg dose will be able to completely eliminate the persistent PEDS in these patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 99 Years

Eligibility

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Age > 50 years

• Active or recurrent neovascular age-related macular degeneration involving the fovea on FA

• Presence of persistent fibrovascular pigment epithelial detachment on OCT following a minimum 6 previous treatments in previous 12 months with ranibizumab and/or bevacizumab. Patients may have received more than 12 months of anti-VEGF therapy.

• ETDRS Best Corrected Visual acuity 20/32 - 20/400

Exclusion Criteria:

• Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy, Previous subfoveal focal laser photocoagulation involving the foveal center, History of vitrectomy, submacular surgery, or other surgical intervention for AMD, Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) in study eye.

• Lesion Characteristics: Subfoveal fibrosis or atrophy in study eye, CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.

• Concurrent Ocular Conditions: Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma), Any concurrent intraocular condition in the study eye (e.g., diabetic retinopathy or glaucoma) 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 over the 12-month study period, Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye

• Current vitreous hemorrhage in the study eye

• History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye

• Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

• Aphakia or absence of the posterior capsule in the study eye unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.

• Uncontrolled glaucoma in the study eye (defined as intraocular pressure 30 mmHg despite treatment with anti-glaucoma medication)

Concurrent Systemic Conditions

• Pregnancy or premenopausal women not using adequate contraception The following are considered effective means of contraception: surgical sterilization; 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.

• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications

Other

• Inability to dilate pupils sufficient for adequate fluorescein angiography

• Inability to comply with study or follow up procedures

Subjects who meet any of the following criteria will be excluded from this study:

• Pregnancy (positive pregnancy test)

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Retinal Detachment
• Retinal Pigment Epithelial Detachment
• Wet Macular Degeneration

Intervention

Drug:
• ranibizumab
2mg intravitreal injection monthly
• ranibizumab
2mg monthly x 3 doses, then as needed based on recurrence of activity on OCT

Locations

Country	Name	City	State
United States	Retina Associates of Kentucky	Lexington	Kentucky
United States	Tennessee Retina	Nashville	Tennessee
United States	Pacific Eye Associates	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Anne Fung MD	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in visual acuity from baseline to 24 months	Best corrected visual acuity on the ETDRS chart at 4 meters will be compared	24 months	No
Secondary	Visual acuity from baseline to 6 months	BCVA on ETDRS will be compared from baseline to 6 months	6 months	No
Secondary	Safety	incidence and severity of ocular and non-ocular adverse events will be evaluated through 12 months	12 months	Yes
Secondary	% with > 15 ETDRS letter gain from baseline through 12 months		12 months	No
Secondary	Change in OCT CST from baseline through 6 and 12 months		12 months	No
Secondary	Time to recurrence of PED in PRN Arm		12 months	No

External Links

•   Pacific Eye Associates
•   Retina Associates of Kentucky
•   Tennessee Retina