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"To study the safety and efficacy of Pegaptanib eye injection in the treatment of retinal bleeding due to myopia"

Intravitreal Pegaptanib for treatment of Choroidal Neovascularisation secoundary to Pathologic Myopia-A Pilot Study - INJECT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/07/001919
Enrollment
20
Registered
2011-07-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Myopic Choroidal Neovascular Memberane

Interventions

Intervention1: Intravitreal Pegaptanib 0.3 mg: 0.3mg, every 6 weeks until visit 2(duration12 weeks). Control Intervention1: No comparator agent, since this being single arm interventional study: No

Sponsors

LVPrasad Eye Institute
Lead Sponsor
Omnicare Clinical Research Regulatory and Start Up Activities
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Should be willing to participate in the trial. 2.Age less than 55 years. 3.Best corrected visual acuity (BCVA) score of at least 5 letters (20/200), as assessed by ETDRS chart. 4.Myopia of greater than or equal to 6 Diopters. 5.Fluorescein angiographic documentation of CNV.

Exclusion criteria

Exclusion criteria: 1.Ocular causes, or other ocular disorders leading to vision loss. 2.Maculopathy not related to pathologic myopia. 3.Pregnancy, lactation. 4.Not willing to provide an informed consent. 5.History of previous macular laser including PDT. 6.Other forms of therapy including intravitreal injections. 7.History of intraocular surgery in the past 3 months. 8.Anticipated cataract surgery in the next 6 months. 9.Any active infection or inflammation in the eye. 10.Cases where good quality imaging is not possible, either due to hazy media or extremely high myopia. 11.Patients with uncontrolled glaucoma, with IOP 21mm Hg on 2 or more medications. 12.Patients with subfoveal scar or significant subretinal haemorrhage occupying more than 50% of lesion size. 13.Eyes with previous retinal detachment.

Design outcomes

Primary

MeasureTime frame
Mean change in visual acuityTimepoint: baseline to 54 weeks

Secondary

MeasureTime frame
1.Mean visual acuity 2. Mean change in macular thickness on OCT 3.3. Proportion of patients showing >0, 5, 10 and 15 letter gain and < 15 letter loss fromTimepoint: baseline to 54 weeks

Countries

India

Contacts

Public ContactDrSridevi Rayasam

L.V.Prasad Eye Institute

narayanan@lvpei.org040-30612618

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026